October 2024 EMA/CHMP batch of positive opinions

The European Medicines Agency’s (EMA) human health committee, CHMP, announced six positive opinions of novel medicines, as well as two biosimilars, following its October meeting.

The committee recommended granting a marketing authorization for Danish firm Novo Nordisk’s (NOV: N) Alhemo (concizumab), a medicine for routine prophylaxis of bleeding in patients with hemophilia A or B with inhibitors, two types of a rare inherited bleeding disorder. If approved, Alhemo would be the first once-daily subcutaneous prophylactic treatment for people aged 12 years or older living with hemophilia A or B with inhibitors.

The CHMP adopted positive opinions for two vaccines – both from CSL Limited’s (ASX: CSL) Seqirus subsidiary - intended for active immunization against influenza: Fluad (surface antigen, inactivated, adjuvanted), intended for adults 50 years of age and older, and Flucelvax (surface antigen, inactivated, prepared in cell cultures), for adults and children from two years of age.