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Key European committee backs GWs Epidyolex, Bayers Vitrakvi and more

July 26, 2019 / Eric Sagonowsky

In a busy meeting this week, experts with the European Medicines Agencys Committee for Medicinal Products for Human Use endorsed four new drugs, a Mylan generic, and numerous new indications for already-marketed meds. All the recommendations will go to the European Commission for final approval. Aside from those decisions, the committee also endorsed a new generic from Mylan to Novartis’ Exjade, which treats chronic iron overload. The drug generated $578 million outside the U.S. last year. And the experts signed off on label expansions from several meds including Merck’s Keytruda, Alexion’s Soliris, Johnson & Johnson’s Stelara and Roche’s Tecentriq. Some drugs CHMP previously rejected will get new reviews. UCB's Evenity for osteoporosis will get another look after a previous rejection, and experts will review label expansions for Novartis’ Revolade and PTC Therapeutics’ Translarna after rejecting earlier bids.