Europe – Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2024

Eight new medicines recommended for approval

EMA’s human medicines committee (CHMP) recommended eight medicines for approval at its April 2024 meeting.

The CHMP recommended granting a marketing authorisation for Altuvoct* (efanesoctocog alfa), for the treatment and prophylaxis of bleeding in patients with haemophilia A, a rare inherited bleeding disorder caused by lack of factor VIII.

The committee adopted a positive opinion for Fruzaqla (fruquintinib), indicated for the treatment of patients with previously treated metastatic colorectal cancer.

The CHMP gave a positive opinion for Jeraygo (aprocitentan), for the treatment of resistant hypertension.

Obgemsa (vibegron) received a positive opinion for the treatment of adults with overactive bladder syndrome.

The CHMP gave a positive opinion for Truqap (capivasertib), for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations…