EU Crunch Time For Two Drugs That Lost Their Fast-Track Status
Karyopharm and GSK should soon learn whether the European Medicines Agency will recommend EU approval for their respective products, selinexor and dostarlimab.
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The sponsors of seven new drugs are set to find out this week whether the European Medicines Agency’s human medicines committee, the CHMP, will recommend pan-EU approval for their products. CHMP action is also expected regarding two potential combination therapies for COVID-19.
New products from Paion, Arvelle, Incyte and many others have been recommended for approval by the European Medicines Agency. Meanwhile, the agency has explained why the EU marketing authorization application for Dexamethasone Taw, for treating COVID-19 patients, was withdrawn.
Karyopharm says its treatment for patients with refractory multiple myeloma could become its first product to be approved in Europe.