EMA to pull Amgen’s Tavneos over ‘incorrect and misleading’ data
· nuala moran
AI Briefing
- • EMA recommends withdrawing Amgen's Tavneos from European market due to incorrect and misleading data.
- • Tavneos, a complement inhibitor, had been approved for treating IgA nephropathy and granulomatosis with polyangiitis.
- • EMA's decision is based on re-evaluation of data provided during the marketing authorisation application assessment.
Context
The European Medicines Agency is recommending that Amgen's Tavneos be withdrawn from the European market. The agency found that data provided for the medicine's assessment were incorrect and misleading.
The withdrawal recommendation matters because it affects the demonstration of Tavneos' effectiveness, which can no longer be relied upon due to the incorrect data.
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