The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended revoking the European Union marketing authorization for Tavneos, a treatment for anti-neutrophil cytoplasmic autoantibody-associated vasculitis (AAV), after concluding that the medicine’s benefits are no longer proven to outweigh its risks.
The recommendation follows a review that began earlier this year over concerns about the integrity of data from the Advocate study, the main clinical trial supporting the drug’s approval. Tavneos was approved in the European Union in 2022 for active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), two forms of AAV.
When the drug was originally authorized, European regulators determined from the 331-patient Advocate study that Tavneos was at least as effective as a 20-week course of high-dose corticosteroids in inducing remission in patients with active GPA or MPA.
Following its review, however, the CHMP concluded that the Advocate study had been conducted in breach of good clinical practice principles. The committee said the data submitted for assessment were incorrect and misleading and could no longer be relied upon to demonstrate the medicine’s effectiveness.
The CHMP also determined that post-marketing data and additional analyses conducted after the main study were not sufficient to support the drug’s benefits. The EMA similarly stated that evidence collected after approval, together with further analyses, did not adequately establish the medicine’s effectiveness.
A final decision now rests with the European Commission, which is expected to make a determination shortly. Vifor Fresenius Medical Care Renal Pharma and CSL, which market Tavneos in Europe, said they expect a decision in the near future.
Bill Mezzanotte, head of research and development at CSL, said, “While we are disappointed in the outcome of the Article 20 procedure, we will respect the outcome of the regulatory process and are committed to implementing it in full.”
The CHMP has recommended that no new patients begin treatment with Tavneos and that existing patients be switched to suitable alternatives. CSL also advised patients currently receiving the medicine to discuss next steps with their physicians.
The European recommendation comes as Tavneos is also under review in the United States. Earlier this year, the U.S. Food and Drug Administration formally proposed withdrawing the drug’s approval after raising concerns regarding its efficacy and safety. The FDA identified 76 cases of drug-induced liver injury with evidence suggesting a causal link to the medicine.
Amgen, which markets Tavneos in the United States, declined an FDA request earlier this year to stop selling the drug. The company is preparing for a hearing with the agency and recently received a one-month extension for submitting information. The deadline has been extended to July 29 from June 29.
In a statement, Amgen said it was deeply concerned about the potential impact of the CHMP recommendation on patients and healthcare providers and maintained that Tavneos remains an important treatment option for people living with AAV. The company said it continues to believe the medicine has a favorable benefit-risk profile based on available data, including more than 20 real-world studies. Amgen also noted that CSL is leading interactions with the EMA regarding the product in Europe.
The company has signed up a research firm to independently review the Tavneos data as it prepares for the FDA hearing. CSL also said that the United Kingdom’s medicines regulator is investigating the drug, while noting that there has been no change to Tavneos’ UK marketing authorization.
Tavneos has encountered a significant regulatory challenge after the European Medicines Agency (EMA) committee recommended revoking its European Union marketing authorization. The recommendation follows a detailed review of supporting clinical trial data and the medicine’s overall benefit-risk profile. While the decision is not yet final, it represents an important development for Tavneos, healthcare providers, and patients who rely on the treatment.
EMA Committee Reviews Tavneos Clinical Evidence
The EMA committee conducted a comprehensive assessment of the clinical evidence supporting Tavneos, examining data from pivotal and follow-up studies. The review focused on whether the available evidence continued to demonstrate a favorable balance between the medicine’s benefits and potential risks.
Based on its evaluation, the committee concluded that the current supporting data did not sufficiently justify maintaining the existing EU approval for Tavneos.
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