Europe’s medicines committee closed its October meeting with 21 opinions: six recommendations for new marketing authorisations, nine extensions of indication for medicines already on the market, and six generic approvals, the European Medicines Agency said in its meeting highlights. The best known of the new medicines, Eli Lilly’s oral GLP-1 Foundayo, was published on this site this morning by the catalyst watcher and is not repeated here.
The shape of the list is the information. Extensions of indication, new uses for existing products, outnumbered new drugs nine to six, the pattern of a mature regulatory year in which value is created by widening labels on proven molecules rather than by first in class risk. Generics, at six, keep the other end of the market moving, eroding the same franchises the extensions defend.
Each positive opinion now goes to the European Commission, which issues the legally binding decision, usually within about two months. For investors the CHMP highlights are the queue: what the committee backs in October is what companies can sell, and guide on, in the new year.