Eight new drugs recommended for approval: Altuvoct (efanesoctocog alfa), Fruzaqla (fruquintinib), Jeraygo (aprocitentan), Obgemsa (vibegron), Truqap (capivasertib). The committee adopted positive opinions for two biosimilar drugs and on the extension of the therapeutic indication for six drugs.
Eight new drugs recommended for approval
At its April 2024 meeting, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended the approval of eight medicines
Altuvoct (efanesoctocog alfa), for the treatment and prophylaxis of bleeding in patients with haemophilia A, a rare hereditary haemorrhagic disease caused by the lack of factor VIII.
Fruzaqla (fruquintinib), indicated for the treatment of patients with previously treated metastatic colorectal cancer.
Jeraygo (aprocitentan), for the treatment of resistant hypertension.
Obgemsa (vibegron) has received a positive opinion for the treatment of adults with overactive bladder syndrome.
Truqap (capivasertib), for the treatment of locally advanced or metastatic breast cancer with one or more specific mutations.
The committee adopted positive opinions for two biosimilar medicines:
Tofidence (tocilizumab), for the treatment of rheumatoid arthritis, COVID-19, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.
Wezenla (ustekinumab), for the treatment of plaque psoriasis, including pediatric plaque psoriasis, psoriatic arthritis, and Crohn’s disease.
A positive opinion has been adopted for Eribulin Baxter (eribulin), a generic medicine indicated for the treatment of breast cancer and liposarcoma, a rare tumor that develops in fatty tissue.
Withdrawal of questions
Two marketing authorization applications have been withdrawn: GeGant, a radionuclide generator that can be used by doctors to label diagnostic drugs, and Upstelda, a biosimilar for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease. Upstelda is a duplicate of Wezenla.
A Q&A document on the GeGant retirement is available in the grid below.
Recommendations on the extension of the therapeutic indication for six drugs
The committee recommended the extension of the therapeutic indication for six medicines already authorized in the European Union (EU): Alecensa, Opdivo, Rozlytrek, Rybrevant, Sirturo and Triumeq.
