EMA’s CHMP announces April 2024 recommendations for approval

The European Medicines Agency’s (EMA) human medicines committee (CHMP) recommended five novel medicines for approval at its April 2024 meeting, as well as two biosimilars.

The CHMP recommended granting a marketing authorization for Altuvoct (efanesoctocog alfa), from Swedish Orphan Biovitrum (STO: SOBI), for the treatment and prophylaxis of bleeding in patients with hemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII. Efanesoctocog alfa is a once-weekly and high-sustained factor VIII replacement therapy for patients of all ages and any disease severity.

The committee adopted a positive opinion for Japanese pharma major Takeda’s (TYO: 4502) Fruzaqla (fruquintinib), indicated for the treatment of patients with previously treated metastatic colorectal cancer. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the European Union for previously treated mCRC.