Zero Success For Companies Appealing Negative CHMP Opinions In EU Last Year
All five of the appeals against negative opinions for new drug applications that the European Medicines Agency completed last year met with failure. On the positive side, 92 new medicines were granted positive opinions, of which 35 contained new active substances.
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The European Medicines Agency asks companies to wait until they know for certain whether their marketing authorization applications will be approved or not before making any public announcement. Despite this, some companies go public as soon as they hear an early, but non-binding, verdict. The Pink Sheet looks at the issue of “trend votes” and at the companies who decide not to wait.
Puma Biotech has proven to be the cat with nine lives after its HER2+ breast cancer treatment neratinib received a u-turn from CHMP, granting it a positive trend vote. But even if final marketing approval is granted this year, European prospects don’t necessarily follow.
Sarepta is expecting the European Medicines Agency to recommend against EU approval of its Duchenne muscular dystrophy treatment eteplirsen. Persuading the agency to change its mind during the appeal will be an uphill task for the company.