CHMP recommends revoking EU marketing authorisation for TAVNEOS

Regulation Impact 4
โดย Vifor Fresenius Medical Care Renal Pharma and CSL·Read original
Summary · why it matters

The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended revoking the European Union marketing authorisation for TAVNEOS, a treatment for adults with severe, active granulomatosis with polyangiitis or microscopic polyangiitis. The recommendation follows an Article 20 non-pharmacovigilance procedure initiated due to concerns related to data handling in the pivotal Phase 3 ADVOCATE trial. The opinion has been sent to the European Commission, and a final decision is expected shortly; if confirmed, TAVNEOS will no longer be authorised in the EU. No new patients will be treated with TAVNEOS in the EU and European Economic Area, and current patients are advised to consult their physician. Vifor Fresenius Medical Care Renal Pharma and CSL, which commercialise TAVNEOS outside the US under a license from ChemoCentryx, stated they will respect the regulatory outcome and are working to ensure a compliant treatment transition.

Impact on stocks 3

Health Care▼ · 1 stocks
Fresenius Medical Care AG & Co. KGaA
FME
▼ NegativeRegulationrelevance

CHMP recommends revoking EU marketing authorisation for TAVNEOS, which is commercialised by Vifor Fresenius Medical Care Renal Pharma, a joint venture partly owned by Fresenius Medical Care

Biotech & Genomic Medicine▲ · 1 stocks
Climate Adaptation & Water▲ · 1 stocks

Theme Impact 1

Off-coverage companies 2

Vifor Fresenius Medical Care Renal Pharma (VFMCRP)Private▼ Negative
Regulationrelevance

Vifor Fresenius Medical Care Renal Pharma commercializes TAVNEOS outside US; CHMP recommends revoking EU authorization, directly affecting its product

CSL LimitedPrivate▼ Negative
Regulationrelevance

CSL commercializes TAVNEOS outside US; CHMP recommends revoking EU marketing authorization, impacting sales

Related news

▲

Bristol Myers Sotyktu Shows Two-Year PsA Efficacy in POETYK Study

Bristol Myers Squibb announced positive two-year results from the late-stage POETYK PsA-2 study of Sotyktu, or deucravacitinib, including its open-label extension. Among patients entering the extension, clinical responses improved from week 16 through week 52 and were sustained through week 104, with robust results across ACR20/50/70 and Minimal Disease Activity in both continuous Sotyktu patients and those who switched from placebo at week 16. The safety profile remained consistent through week 104 with no new safety signals; adverse events occurred in 86.6% of 604 patients exposed to Sotyktu, while serious adverse events and discontinuations due to adverse events were reported in 12.6% and 7.6% of patients, respectively. Sotyktu, an oral selective tyrosine kinase 2 inhibitor approved in the United States and numerous other countries for moderate-to-severe plaque psoriasis and active psoriatic arthritis, generated $156 million in first-half 2026 revenues, up 24% year over year. Data from the POETYK SLE-1 and SLE-2 studies in systemic lupus erythematosus are expected later in 2026, while Amgen's Otezla and Takeda's investigational zasocitinib, whose new drug application the FDA recently accepted for plaque psoriasis, remain competitive threats.
BMY ▲
Biotech & Genomic Medicine ▲
Zacks Investment Research·12hRead more →
3

Novo's Denecimig Wins CHMP Backing for Hemophilia A in EU

Novo Nordisk said the European Medicines Agency's Committee for Medicinal Products for Human Use has issued a positive opinion recommending approval of denecimig, also known as Mim8, for the treatment of hemophilia A, with or without inhibitors, in adults and children. Denecimig is a next-generation factor VIIIa mimetic bispecific antibody given subcutaneously as routine prophylaxis, with flexible dosing that includes once-monthly, every-two-week and weekly administration, and it is being developed as a prefilled pen. Novo expects to launch the drug in the first European countries in the fourth quarter of 2026 under the brand name Frehemgo, followed by a broader rollout across the European Union beginning in early 2027. The positive opinion is supported by data from the FRONTIER clinical program, which comprises five studies evaluating denecimig as a prophylactic treatment for hemophilia A across pediatric and adult populations, with or without inhibitors; in the FRONTIER 2 study denecimig significantly reduced annualized bleeding rates, results in children younger than 12 in FRONTIER 3 were consistent with those in adolescents and adults, and in FRONTIER 5 no new safety concerns were identified when participants switched directly from emicizumab to denecimig. The candidate is also under regulatory review in the United States for routine prophylaxis in adults and children with hemophilia A, with or without inhibitors, after Novo submitted a biologics license application to the FDA in September 2025. Novo already markets Alhemo for hemophilia A and B in patients with or without inhibitors.
ACIUALDXNOV.XETRAPGEN
Biotech & Genomic Medicine ▲
Zacks Investment Research·15hRead more →
▼impact 4

Trump to Announce Most Favored Nation Drug Pricing for Medicaid in All 50 States

President Trump will announce on Friday that Medicaid beneficiaries in all 50 states will receive Most Favored Nation pricing discounts on some prescription drugs. The White House Council of Economic Advisers projects the move will generate $27.6B in savings for state governments and $36.6B for the federal government over 10 years, according to Semafor, which broke the news. Trump is also scheduled to meet today with the governors of Arkansas, Mississippi, and South Dakota to discuss progress on lowering drug prices. Separately, an AARP Public Policy Institute report released in August found that applying MFN pricing to the top 10 drugs by Medicare Part D and Part B spending in 2025 would cut Medicare spending on those drugs from $273B to $76B between 2029 and 2033.
ABBVJNJLLYMRKNOV.XETRAPFE+1
Biotech & Genomic Medicine ▼
Seeking Alpha·16hRead more →
© 2026 MarketDXNews