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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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.
The EMA’s CHMP has adopted positive opinions on two more biosimilar products: trastuzumab and infliximab. Sixteen biosimilars remain under review at the agency.
The UK drug regulator has granted volanesorsen a positive scientific opinion under its early access to medicines scheme for use in patients with familial chylomicronemia syndrome. The drug’s sponsor, Akcea Therapeutics, is hoping to get the drug approved in the EU, the US and Canada this year.