CHMP RECOMMENDED GRANTING MARKETING AUTHORIZATION FOR ROPEGINTERFERON
Breaking news for ropeginterferon: CHMP (The Committee for Medicinal Products for Human Use; European Medicines Agency’s committee responsible for elaborating the agency’s opinions on all issues regarding medicinal products for human use) has given a positive opinion on the drug and recommended granting market authorization. If approved, this will be the first time an interferon has been developed specifically for MPN. Many patients use a version of interferon off-label now, but there is doubt about supply and access for patients globally as the manufacturer of at least one version widely taken – Pegasys – has declined so far to seek approval for its use in myeloproliferative neoplasms.
The drug will be called Besremi, at least in the European market. Pharmaessentia is also talking to FDA about approval in the US.
We are excited about the opportunity to give more people with MPN access to medications that can help them live longer, healthier lives. We will keep you up to date with the latest on this and any other drug or research news for PV, ET and MF.
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