Numerous factors go into Decision Resource Group’s market forecasts. One of the major aspects is deciding whether a drug will launch. We routinely assess historical data when building our assumptions for the most likely future outcome. In Europe, the Committee for Proprietary Medicinal Products (CHMP) is the European Medicines Agency's (EMA) committee responsible for human medicines. For a drug to be approved by the EMA, the CHMP must give a positive opinion.
Since the beginning of the year, several drug companies have received negative opinions from the CHMP. Following a negative opinion from the European agency, companies have 60 days to request a re-examination of the opinion, detailing the grounds under which they are appealing. Three companies are currently awaiting the outcomes of these requests; Radius Health’s osteoporosis therapy Tymlos/Eladynos (abaloparatide); Portola Pharmaceuticals’ anticoagulant Bevyxxa (betrixaban); and Puma Biotechnology’s breast cancer therapy Nerlynx (Neratinib).
We examined CHMP historical data since 2013 to assess the chances of these outcomes being overturned. Of the 28 drugs that have received a negative opinion in that time, 71% asked for a re-examination. Of those, only 25% of re-examinations had the negative opinion over-turned. Tymlos, Bevyxxa, and Nerlynx have all been approved by the FDA in the United States. Delving deeper, we assessed if prior FDA approval improved a drug’s chances of subsequently being approved in Europe. Eight drugs re-examined by the CHMP were FDA approved. For these drugs, the odds of having the initial negative opinion over-turned improved markedly, doubling to 50%.
Therefore, history would suggest that one or two out of the three drugs currently being re-examined will receive a positive opinion. Radius Health, Portola Pharmaceuticals, and Puma Biotechnology will all be hoping they’re on the correct side of fortune.
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