Volanesorsen, Inotersen And Erenumab Nearing End Of EU Review Process
Some 17 products are in the late stages of evaluation at the European Medicines Agency, including half a dozen orphans, a handful of other new drugs, and a clutch of biosimilars.
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Six orphan drugs – including the first two CAR-T cell therapies in the EU – may get the green light from the European Medicines Agency at its June meeting this week. Will the negative opinion handed down earlier this year on Puma Biotechnology’s Nerlynx be overturned, though?
The European Medicines Agency's drug evaluation committee, the CHMP, will this week decide whether up to a dozen products that have been through the evaluation process should be recommended for approval in throughout the EU.
Kite and Novartis are vying to be the first company to have a CAR-T therapy approved in the EU. Both companies are hoping to be able to treat patients with r/r DLBCL.