CHMP backs Besremi for polycythemia vera, two Shionogi drugs

EMA's CHMP recommended a basket of approvals and label extensions on Friday, including Orphan Drug Besremi ropeginterferon alfa-2b to treat polycythemia vera and a pair of treatments from Shionogi & Co. Ltd. (Tokyo:4507).

The agency backed Besremi from AOP Orphan Pharmaceuticals AG (Vienna, Austria) to treat polycythemia vera without symptomatic splenomegaly. AOP has rights to the long-acting pegylated interferon α-2b from PharmaEssentia Corp. (TPEx:6446)...