{"schema_version":"1.0","type":"article","title":"IgA nephropathy drugs: monthly shots will win","url":"https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en.html","markdown_url":"https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en.md","lang":"en","date":"2026-10-27","publish_at":"2026-10-27T08:00:00+08:00","updated_at":"2026-10-27","category":"商業分析系列","topic":"商業分析系列","tags":["IgA nephropathy","dialysis","Voyxact","Trutakna","povetacicept"],"summary":"Two-year data are in: on placebo, IgA nephropathy patients lost 4-6 eGFR points a year; on new APRIL-pathway drugs, almost none. Monthly Voyxact and povetacicept will beat weekly, pricier Trutakna.","key_points":["Otsuka's Voyxact will win full FDA approval for IgA nephropathy before Vera's Trutakna, and Vertex's povetacicept will win accelerated approval by its November 30, 2026 FDA deadline; the two every-four-weeks drugs will lead weekly Trutakna.","Two-year data released October 22, 2026 showed eGFR rising 0.3 points a year on Voyxact versus falling 4.2 on placebo (VISIONARY, 510 patients), and falling 0.6 on telitacicept versus 5.7 on placebo (TELIGAN, 318 patients).","Vera's Trutakna won FDA accelerated approval on July 7, 2026 as a weekly injection with a US list price of $425,000 a year, above the $390,000 for Otsuka's every-four-weeks Voyxact."],"facts":[{"claim":"People on dialysis in Taiwan","value":"more than 90,000","unit":"patients","as_of":"2025-12-05","source":"https://www.ctee.com.tw/news/20251206700062-430101"},{"claim":"Dialysis-related spending in Taiwan (2025)","value":"nearly 500","unit":"NT$100 million","as_of":"2025-12-05","source":"https://www.ctee.com.tw/news/20251206700062-430101"},{"claim":"IgA nephropathy share of primary glomerulonephritis biopsies in Taiwan","value":"about 26","unit":"%","as_of":"2024-04-16","source":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11021013/"},{"claim":"Patients randomized in VISIONARY","value":510,"unit":"patients","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Two-year annual eGFR slope on Voyxact","value":0.3,"unit":"mL/min/1.73m² per year","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Two-year annual eGFR slope on placebo in VISIONARY","value":-4.2,"unit":"mL/min/1.73m² per year","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Voyxact eGFR slope difference vs placebo","value":4.5,"unit":"mL/min/1.73m² per year","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"VISIONARY composite kidney events, Voyxact vs placebo","value":"1/259 vs 28/251","unit":"patients","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Voyxact FDA accelerated approval date","value":"2025-11-25","unit":"date","as_of":"2026-10-22","source":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"claim":"Patients in TELIGAN","value":318,"unit":"patients","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"Two-year annual eGFR slope on telitacicept (placebo -5.7)","value":-0.6,"unit":"mL/min/1.73m² per year","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"Telitacicept eGFR slope difference vs placebo","value":5.1,"unit":"mL/min/1.73m² per year","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"Reduction in urine protein (UPCR) from baseline at week 104 on telitacicept","value":60.3,"unit":"%","as_of":"2026-10-22","source":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"claim":"Patients in ORIGIN 3 final analysis","value":428,"unit":"patients","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"Two-year annual eGFR slope on Trutakna (placebo -5.6)","value":-0.6,"unit":"mL/min/1.73m² per year","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"Reduction in risk of disease-progression composite in ORIGIN 3 (11 vs 38 patients)","value":76,"unit":"%","as_of":"2026-09-15","source":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"claim":"Trutakna FDA accelerated approval date","value":"2026-07-07","unit":"date","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Trutakna US annual list price","value":425000,"unit":"USD","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Voyxact US annual wholesale cost","value":390000,"unit":"USD","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Patients enrolled in RAINIER","value":605,"unit":"patients","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"Reduction in urine protein from baseline at week 36 on povetacicept (49.8% placebo-adjusted)","value":52,"unit":"%","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"Povetacicept FDA PDUFA target date","value":"2026-11-30","unit":"date","as_of":"2026-06-01","source":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"claim":"Taiwan sites in VISIONARY / BEYOND","value":"6 / 8","unit":"sites","as_of":"2026-10-23","source":"https://clinicaltrials.gov/study/NCT05248646"},{"claim":"Vera estimate of people with IgA nephropathy in the US","value":160000,"unit":"patients","as_of":"2026-07-07","source":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"claim":"Adult IgAN patients progressing to end-stage kidney disease within 20 years (Vertex)","value":"up to 72","unit":"%","as_of":"2025-10-16","source":"https://seekingalpha.com/pr/20270393-vertex-announces-progress-in-povetacicept-development-program-and-presentation-of-new-data-at"}],"sections":["01 | How IgA nephropathy ends in dialysis","02 | One yardstick: how much kidney is left after two years","03 | With the data tied, the shot count decides","04 | Who leads and who gets squeezed","05 | How far Taiwan's patients are from these drugs","References"],"references":[{"title":"Otsuka Presents Landmark Final Phase 3 VISIONARY Results at ASN","source":"Otsuka America Pharmaceutical","date":"2026-10-22","url":"https://www.otsuka-us.com/Otsuka-Presents-Final-Phase-3-VISIONARY-Results"},{"title":"Telitacicept Demonstrates Durable Preservation of Kidney Function Through Two Years in Phase 3 TELIGAN Trial in IgA Nephropathy","source":"Vor Bio (GlobeNewswire","date":"2026-10-22","url":"https://www.globenewswire.com/news-release/2026/10/22/3386893/0/en/telitacicept-demonstrates-durable-preservation-of-kidney-function-through-two-years-in-phase-3-teligan-trial-in-iga-nephropathy.html"},{"title":"Atacicept Cuts IgAN Progression Risk 76% in ORIGIN 3 Final Data","source":"HCPLive","date":"2026-09-15","url":"https://www.hcplive.com/view/atacicept-cuts-igan-progression-risk-76-in-origin-3-final-data"},{"title":"Atacicept Slows IgAN Decline to Physiologic Rate","source":"HCPLive","date":"2026-09-29","url":"https://www.hcplive.com/view/atacicept-slows-igan-decline-to-physiologic-rate-with-sayna-norouzi-md"},{"title":"FDA approves Vera's Trutakna for IgA nephropathy","source":"BioPharma Dive","date":"2026-07-07","url":"https://www.biopharmadive.com/news/vera-fda-approve-trutakna-IgAN-kidney-disease-atacicept/824620/"},{"title":"Otsuka's Voyxact faces rival as FDA okays Vera IgAN drug","source":"pharmaphorum","date":"2026-07-08","url":"https://pharmaphorum.com/news/otsukas-voyxact-faces-rival-fda-okays-vera-igan-drug"},{"title":"Vertex Announces US FDA Acceptance of Biologics License Application for Accelerated Approval of Povetacicept in IgA Nephropathy","source":"Vertex Pharmaceuticals","date":"2026-06-01","url":"https://investors.vrtx.com/news-releases/news-release-details/vertex-announces-us-fda-acceptance-biologics-license-application"},{"title":"Vor Bio Reports Second Quarter 2026 Financial Results and Provides Corporate Update","source":"Vor Bio","date":"2026-08-11","url":"https://ir.vorbio.com/node/11036/pdf"},{"title":"Review on epidemiology, disease burden, and treatment patterns of IgA nephropathy in select APAC countries","source":"BMC Nephrology","date":"2024-04-16","url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC11021013/"},{"title":"President Lai hopes home dialysis reaches 18% prevalence by 2035 (in Chinese","source":"Commercial Times","date":"2025-12-06","url":"https://www.ctee.com.tw/news/20251206700062-430101"},{"title":"Trial of Sibeprenlimab in the Treatment of IgA Nephropathy (VISIONARY, NCT05248646","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT05248646"},{"title":"A Study of Zigakibart in Adults With IgA Nephropathy (BEYOND, NCT05852938","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT05852938"},{"title":"Monthly Dosing of Atacicept in IgAN (NCT07020923","source":"ClinicalTrials.gov","date":"2026-10-23","url":"https://clinicaltrials.gov/study/NCT07020923"},{"title":"Vertex Announces Progress in Povetacicept Development Program","source":"Vertex Pharmaceuticals (Business Wire","date":"2025-10-16","url":"https://seekingalpha.com/pr/20270393-vertex-announces-progress-in-povetacicept-development-program-and-presentation-of-new-data-at"}],"images":[{"alt":"Fig. 1 | IgAN: four drugs, one signal","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en/figure-01.png"},{"alt":"Fig. 2 | Kidney function saved","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en/figure-02.png"},{"alt":"Fig. 3 | Three US contenders","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en/figure-03.png"},{"alt":"Fig. 4 | Four cards in 13 months","url":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en/figure-04.png"}],"cover_image":"https://drugnews.com.tw/assets/articles/iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en/cover.png","publisher":{"name":"Drugnews｜藥時事","url":"https://drugnews.com.tw/","profile":"https://drugnews.com.tw/brand-profile.json"},"citation":"Drugnews｜藥時事（2026-10-27）。IgA nephropathy drugs: monthly shots will win。https://drugnews.com.tw/articles/2026-10-27-iga-nephropathy-april-drugs-voyxact-trutakna-povetacicept-en.html","disclaimer":"This article is intended for industry research and knowledge sharing only. It does not constitute investment, medical, fundraising, or individual stock advice.","translations":{},"relationship":"independent_editorial","disclosure_url":"https://drugnews.com.tw/policy/"}