{"id":3847,"date":"2021-12-16T00:49:00","date_gmt":"2021-12-16T00:49:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/3608450_AE08450_0"},"modified":"2021-12-16T00:49:00","modified_gmt":"2021-12-16T00:49:00","slug":"everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=3847","title":{"rendered":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy"},"content":{"rendered":"<div><img decoding=\"async\" src=\"https:\/\/en.prnasia.com\/prnasia.com-PC\/images\/logo-en-blue-in.png\" class=\"ff-og-image-inserted\"><\/div>\n<ul type=\"disc\">\n<li><i>TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with <span id=\"spanHghlt6205\">primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) \u22651.5g\/g<sup>1<\/sup><\/span><\/i> <\/li>\n<li><i>TARPEYO (developed under the project name NEFECON) is the first and only <span id=\"spanHghlt78c0\">FDA-approved<\/span> treatment specifically designed for <span id=\"spanHghlt93dc\">this condition<\/span><sup><span id=\"spanHghlte539\">1<\/span>,2<\/sup><\/i> <\/li>\n<li><i>IgAN is a progressive autoimmune disease, which has a high unmet need with more than 50% of patients potentially progressing to end-stage renal disease (ESRD)<sup>3<\/sup><\/i> <\/li>\n<li><i>Everest Medicines has exclusive rights to develop and commercialize <span id=\"spanHghlt0930\">NEFECON<\/span> in Mainland China, <span class=\"xn-location\">Hong Kong<\/span>, <span class=\"xn-location\">Macau<\/span>, <span class=\"xn-location\">Taiwan<\/span> and <span class=\"xn-location\">Singapore<\/span><\/i><\/li>\n<\/ul>\n<p><span id=\"spanHghltc384\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"xn-chron\">Dec. 16, 2021<\/span> \/PRNewswire\/ &#8212; Everest Medicines Limited (HKEX 1952.HK) today reported that Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (&#8220;Calliditas&#8221;) <span id=\"spanHghlt5e42\">announced<\/span> that the US Food and Drug Administration (FDA) has approved TARPEYO<sup><span id=\"spanHghlt620b\">TM<\/span><\/sup> (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN)<span id=\"spanHghlt47ba\">&nbsp;at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) \u22651.5g\/g<\/span>. This indication is approved under accelerated approval. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.<sup>1<\/sup><\/p>\n<p><span id=\"spanHghltb913\">&#8220;We<\/span> are very excited to bring the first and only FDA-approved treatment <span id=\"spanHghlt1d9c\">to reduce proteinuria<\/span> in IgAN to market,&#8221; said Ren\u00e9e Aguiar-Lucander, Chief Executive Officer of Calliditas. &#8220;TARPEYO represents <span id=\"spanHghltbd31\">an FDA approved product<\/span> to help <span id=\"spanHghlt310b\">these<\/span> patients who are at risk of rapid disease progression.&#8221;<\/p>\n<p>&#8220;The<span id=\"spanHghlt6318\">&nbsp;FDA<\/span> approval of <span id=\"spanHghlt3b44\">Calliditas&#8217; novel<\/span> formulation of budesonide<span id=\"spanHghlt1a11\">, which we are advancing in our territory under the development name &#8216;NEFECON&#8217;,<\/span> marks a <span id=\"spanHghlt8e2e\">major<\/span> step forward for IgAN treatment,&#8221; said <span class=\"xn-person\">Kerry Blanchard<\/span>, MD, PhD, CEO of Everest Medicines. &#8220;We congratulate our partner Calliditas on its expedited global clinical and regulatory advancements to make this first-in-disease therapy available to patients in need. At Everest, we look forward to progressing development of this important therapy for patients in <span class=\"xn-location\">Greater China<\/span> and other parts of <span class=\"xn-location\">Asia<\/span>, where there is a high prevalence of IgAN.&#8221;<\/p>\n<p>TARPEYO is approved under accelerated approval based on achieving its primary endpoint of &nbsp;reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study, an ongoing,&nbsp;randomized, double-blind, placebo-controlled, multicenter study conducted to evaluate the&nbsp;efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary <span id=\"spanHghlt67d1\">IgAN<sup>1<\/sup>. The effect of TARPEYO was assessed in patients with biopsy-proven IgAN, eGFR \u226535 mL\/min\/<span class=\"xn-money\">1.73 m<\/span><sup>2<\/sup>, and proteinuria (defined as either \u22651 g\/day or UPCR \u22650.8 g\/g) who were on a stable dose of maximally-tolerated RAS inhibitor therapy.<\/span><\/p>\n<p>Patients taking TARPEYO (n=97) showed a statistically significant 34% reduction in proteinuria&nbsp;from baseline vs 5% with RASi alone (n=102) at 9 months. The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key subgroups, including key&nbsp;demographic&nbsp;and baseline disease characteristics.<sup>1<\/sup> <span id=\"spanHghlt5795\">The most common adverse reactions (\u22655%) in this study were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, and hirsutism. <\/span><\/p>\n<p><span class=\"xn-person\">Richard Lafayette M.D<\/span>., Professor of Medicine at <span class=\"xn-org\">Stanford University<\/span> and the Director of the&nbsp;Stanford Glomerular Disease Center commented, &#8220;IgAN is a tough diagnosis for many patients,&nbsp;and it can progressively lead to the need for dialysis and\/or kidney transplantation. The FDA&nbsp;approval of TARPEYO now offers disease-specific treatment for patients with this complicated&nbsp;disease.&#8221;<\/p>\n<p><span class=\"xn-person\">Richard Philipson<\/span>, Calliditas Chief Medical Officer added, &#8220;TARPEYO <span id=\"spanHghltf44d\">was developed to<\/span> target a root cause of IgAN. The FDA&#8217;s approval of TARPEYO demonstrates our unwavering dedication to patients suffering from IgAN. We would like to thank the patients, researchers and clinical staff who participated in the studies of TARPEYO.&#8221;<\/p>\n<p><span class=\"xn-person\">Bonnie Schneider<\/span>, Director and Co-Founder of the IGA Nephropathy Foundation of America commented,&#8221; It has been a difficult journey not only for our family but for all the <span id=\"spanHghlt93bc\">IgA nephropathy<\/span> patients we serve. <span id=\"spanHghlta7ac\">Having this disease specific option<\/span> has our community very excited.&#8221; <\/p>\n<p><i>For more information, please see <a target=\"_blank\" href=\"https:\/\/www.calliditas.se\/en\/fda-grants-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy-3927\/\" rel=\"nofollow noopener\"><i><span id=\"spanHghlt2189\">Calliditas press release<\/span><\/i><\/a> on this announcement<\/i><\/p>\n<p><b>About NEFECON<\/b> <\/p>\n<p><span id=\"spanHghlt9587\">NEFECON (approved in <span class=\"xn-location\">the United States<\/span> under accelerated approval under the trade name TARPEYOTM) is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism.<\/span> NEFECON was designed as a 4 mg delayed release capsule and is enteric coated so that it would remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer&#8217;s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. It is unclear to what extent NEFECON&#8217;s efficacy is mediated via local effects in the ileum vs systemic effects. In <span class=\"xn-chron\">June 2019<\/span>, Everest Medicines entered into an exclusive, royalty-bearing license agreement with Calliditas, which gives Everest Medicines exclusive rights to develop and commercialize NEFECON in Mainland China, <span class=\"xn-location\">Hong Kong<\/span>, <span class=\"xn-location\">Macau<\/span>, <span class=\"xn-location\">Taiwan<\/span> and <span class=\"xn-location\">Singapore<\/span>. <\/p>\n<p><b>About&nbsp;the&nbsp;NeflgArd Study<\/b><\/p>\n<p>The global clinical trial NeflgArd is an ongoing Phase 3, randomized, double-blind, placebo- controlled, multicenter study to evaluate the efficacy and safety of NEFECON once <span id=\"spanHghltdb36\">daily vs<\/span> placebo in adult patients with primary IgAN (N=360) as an addition to optimized RASi therapy. <\/p>\n<p>Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B, a confirmatory validation study in which no NEFECON treatment will be administered, will assess eGFR at two years. <\/p>\n<p>The trial met its primary objective in Part A of demonstrating a statistically significant reduction in urine protein creatinine ratio, UPCR or proteinuria, after 9 months of treatment with 16 mg once daily of NEFECON compared to placebo. Patients taking NEFECON plus RASi (n=97) showed a statistically significant 34% reduction from baseline vs 5% with RASi alone (n=102) at 9 months, resulting in UPCR reduction of 31% (16% to 42%) p=0.0001<span id=\"spanHghltf00a\">.<\/span><\/p>\n<p><b>About&nbsp;Primary&nbsp;Immunoglobulin&nbsp;A&nbsp;Nephropathy<\/b><\/p>\n<p>Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger&#8217;s Disease) is a&nbsp; progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 are recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney.<sup>4,5<\/sup> This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end-stage renal disease. IgAN most often develops between late teens and late 30s.<sup>5,6<\/sup><\/p>\n<p><b>About Everest Medicines<\/b><\/p>\n<p>Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in <span class=\"xn-location\">China<\/span> and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of ten potentially global first-in-class or best-in-class molecules, many of which are in late-stage clinical development. The Company&#8217;s therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at <a target=\"_blank\" href=\"http:\/\/www.everestmedicines.com\/\" rel=\"nofollow noopener\">www.everestmedicines.com<\/a>. <\/p>\n<p><b>About&nbsp;Calliditas<\/b><\/p>\n<p>Calliditas Therapeutics is a biopharma company headquartered in <span class=\"xn-location\">Stockholm, Sweden<\/span>, focused on identifying, developing, and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit <a target=\"_blank\" href=\"http:\/\/www.calliditas.com\/\" rel=\"nofollow noopener\">www.calliditas.com<\/a> for further information. <\/p>\n<div>\n<table cellspacing=\"0\" cellpadding=\"0\" border=\"0\" class=\"prntblns\">\n<tbody readability=\"29.722222222222\">\n<tr readability=\"6\">\n<td class=\"prngen2\" readability=\"7\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">1. TARPEYOTM (budesonide) [prescribing information]. Stockholm, SE: Calliditas Therapeutics AB; 2021<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"15\">\n<td class=\"prngen2\" readability=\"13\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">2. Fellstrom BC, Barratt J, Cook H, et al. Targeted-release budesonide versus placebo in patients with IgA nephropathy (NEFIGAN): a double-blind, randomised, placebo-controlled phase 2b trial. Lancet. May 27, 2017;389(10084):2117-2127. https:\/\/doi:10.1016\/S0140-6736(17)30550-0<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"31.5\">\n<td class=\"prngen2\" readability=\"24\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">3. Hastings, M. C., Bursac, Z., Julian, B. A., Villa Baca, E., Featherston, J., Woodford, S. Y., Bailey, L., &amp; Wyatt, R. J. (2018). Life Expectancy for Patients From the Southeastern United States With IgA Nephropathy. Kidney Int Rep, 3(1), 99-104. https:\/\/doi.org\/10.1016\/j. ekir.2017.08.008 <\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"8.4923076923077\">\n<td class=\"prngen2\" readability=\"7.7846153846154\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">4. Barratt, J., &amp; Feehally, J. (2005). IgA nephropathy. J Am Soc Nephrol, 16(7), 2088-2097. <a target=\"_blank\" href=\"https:\/\/doi.org\/10.1681\/ASN.2005020134\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/doi.org\/10.1681\/ASN.2005020134<\/a> <\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"12.628491620112\">\n<td class=\"prngen2\" readability=\"10.715083798883\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">5. Barratt, J., Rovin, B. H., Cattran, D., et al. (2020). Why Target the Gut to Treat IgA Nephropathy? Kidney Int Rep, 5(10), 1620-1624. <a target=\"_blank\" href=\"https:\/\/doi.org\/10.1016\/j.ekir.2020.08.009\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/doi.org\/10.1016\/j.ekir.2020.08.009<\/a> <\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"14.663414634146\">\n<td class=\"prngen2\" readability=\"12.219512195122\">\n<p class=\"prnews_p\"><span class=\"prnews_span\">6. Jarrick, S., Lundberg, S., Welander, A., et al. (2019). Mortality in IgA Nephropathy: A Nationwide Population-Based Cohort Study. J Am Soc Nephrol, 30(5), 866-876. <a target=\"_blank\" href=\"https:\/\/doi.org\/10.1681\/ASN.2018101017\" class=\"prnews_a\" rel=\"nofollow noopener\">https:\/\/doi.org\/10.1681\/ASN.2018101017<\/a><\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n","protected":false},"excerpt":{"rendered":"<p>TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) \u22651.5g\/g1 TARPEYO (developed under the project name NEFECON) is the first and only FDA-approved treatment specifically designed for this condition1,2 [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":3848,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-3847","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=3847\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog\" \/>\n<meta property=\"og:description\" content=\"TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) \u22651.5g\/g1 TARPEYO (developed under the project name NEFECON) is the first and only FDA-approved treatment specifically designed for this condition1,2 [&hellip;]\" \/>\n<meta property=\"og:url\" content=\"https:\/\/transmediavictoria.net.au\/?p=3847\" \/>\n<meta property=\"og:site_name\" content=\"My Blog\" \/>\n<meta property=\"article:published_time\" content=\"2021-12-16T00:49:00+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png\" \/>\n\t<meta property=\"og:image:width\" content=\"200\" \/>\n\t<meta property=\"og:image:height\" content=\"200\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"admin_tony\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"admin_tony\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#article\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847\"},\"author\":{\"name\":\"admin_tony\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"headline\":\"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy\",\"datePublished\":\"2021-12-16T00:49:00+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847\"},\"wordCount\":1402,\"image\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/transmediavictoria.net.au\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png\",\"articleSection\":[\"Business News\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847\",\"name\":\"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog\",\"isPartOf\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#primaryimage\"},\"image\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#primaryimage\"},\"thumbnailUrl\":\"https:\\\/\\\/transmediavictoria.net.au\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png\",\"datePublished\":\"2021-12-16T00:49:00+00:00\",\"author\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\"},\"breadcrumb\":{\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#primaryimage\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png\",\"contentUrl\":\"https:\\\/\\\/transmediavictoria.net.au\\\/wp-content\\\/uploads\\\/2021\\\/12\\\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png\",\"width\":200,\"height\":200},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?p=3847#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#website\",\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/\",\"name\":\"My Blog\",\"description\":\"My WordPress Blog\",\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/transmediavictoria.net.au\\\/#\\\/schema\\\/person\\\/5b51d407d652c0aa802bea269ea5d7e7\",\"name\":\"admin_tony\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"contentUrl\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g\",\"caption\":\"admin_tony\"},\"url\":\"https:\\\/\\\/transmediavictoria.net.au\\\/?author=8\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/transmediavictoria.net.au\/?p=3847","og_locale":"en_US","og_type":"article","og_title":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog","og_description":"TARPEYO (budesonide) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) \u22651.5g\/g1 TARPEYO (developed under the project name NEFECON) is the first and only FDA-approved treatment specifically designed for this condition1,2 [&hellip;]","og_url":"https:\/\/transmediavictoria.net.au\/?p=3847","og_site_name":"My Blog","article_published_time":"2021-12-16T00:49:00+00:00","og_image":[{"width":200,"height":200,"url":"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png","type":"image\/png"}],"author":"admin_tony","twitter_card":"summary_large_image","twitter_misc":{"Written by":"admin_tony","Est. reading time":"7 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/transmediavictoria.net.au\/?p=3847#article","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847"},"author":{"name":"admin_tony","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"headline":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy","datePublished":"2021-12-16T00:49:00+00:00","mainEntityOfPage":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847"},"wordCount":1402,"image":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847#primaryimage"},"thumbnailUrl":"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png","articleSection":["Business News"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/transmediavictoria.net.au\/?p=3847","url":"https:\/\/transmediavictoria.net.au\/?p=3847","name":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy - My Blog","isPartOf":{"@id":"https:\/\/transmediavictoria.net.au\/#website"},"primaryImageOfPage":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847#primaryimage"},"image":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847#primaryimage"},"thumbnailUrl":"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png","datePublished":"2021-12-16T00:49:00+00:00","author":{"@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7"},"breadcrumb":{"@id":"https:\/\/transmediavictoria.net.au\/?p=3847#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/transmediavictoria.net.au\/?p=3847"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/transmediavictoria.net.au\/?p=3847#primaryimage","url":"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png","contentUrl":"https:\/\/transmediavictoria.net.au\/wp-content\/uploads\/2021\/12\/everest-medicines-announces-fda-grants-our-partner-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce-proteinuria-in-iga-nephropathy.png","width":200,"height":200},{"@type":"BreadcrumbList","@id":"https:\/\/transmediavictoria.net.au\/?p=3847#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/transmediavictoria.net.au\/"},{"@type":"ListItem","position":2,"name":"Everest Medicines announces FDA grants our Partner Calliditas Therapeutics Accelerated Approval of TARPEYO\u2122 (budesonide) to Reduce Proteinuria in IgA Nephropathy"}]},{"@type":"WebSite","@id":"https:\/\/transmediavictoria.net.au\/#website","url":"https:\/\/transmediavictoria.net.au\/","name":"My Blog","description":"My WordPress Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/transmediavictoria.net.au\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/transmediavictoria.net.au\/#\/schema\/person\/5b51d407d652c0aa802bea269ea5d7e7","name":"admin_tony","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","url":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/102836fe5f9cd6c64e96e90e7341dbc815b7d12726a85708326dc0db40afd906?s=96&d=mm&r=g","caption":"admin_tony"},"url":"https:\/\/transmediavictoria.net.au\/?author=8"}]}},"_links":{"self":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/3847","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/users\/8"}],"replies":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3847"}],"version-history":[{"count":0,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/posts\/3847\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=\/wp\/v2\/media\/3848"}],"wp:attachment":[{"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3847"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3847"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/transmediavictoria.net.au\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3847"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}