Experts in Europe recommended 4 new drugs for approval, plus a Mylan generic. The group also signed off on several label expansions. (“EU Flagga” (CC BY-SA 2.0) by MPD01605)
In a busy meeting this week, experts with the European Medicines Agency’s Committee for Medicinal Products for Human Use endorsed four new drugs, a Mylan generic, and numerous new indications for already-marketed meds.
Recommendations for approval:
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GW Pharmaceuticals’ Epidyolex, the closely watched cannabis-based drug to treat seizures associated with Lennox-Gastaut syndrome or Dravet syndrome, now looks set for its European nod. The drug, sold as Epidiolex in the U.S, won CHMP backing and now awaits a final E.U. decision within two months, GW said. CEO Justin Gover said in a statement that the company is “excited by the potential to bring patients and physicians a rigorously tested and evaluated cannabis-based medicine.”
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Acorda, which suffered a big patent loss for Ampyra in the U.S. last year, looks set to roll with Inbrija in Europe in the coming months. CHMP officials endorsed the med to treat symptoms of “off” periods for patients with Parkinson’s disease. Last year, Acorda lost its Ampyra patent protection in the U.S., forcing it to cut cost and jobs, and switch gears to focus on the newer med.
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Bayer’s Vitrakvi, a “tumor-agnostic” drug that targets solid tumors with the NTRK gene fusion, scored a CHMP recommendation for conditional marketing approval. In the U.S., the drug scored an approval in November 2018.
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Taiwan’s Theratechnologies scored an endorsement for Trogarzo, an HIV drug with a novel mechanism of action. Trogarzo won U.S. FDA approval last March.
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.
