EU gives green light for 12 new medicines
The European Medicines Agency (EMA) has recommended the approval of 12 new products at its September meeting. This brings the number of new medicines approved this year to 66.
The EMA’s human medicines committee (CHMP) also backed extensions to the therapeutic indications of a further 11 medicines. The expert recommendations, made after extensive analysis of clinical information, must be formally approved by the European Commission.
The committee gave the green light for the following:
- Frehemgo (denecimig) for the prophylaxis of bleeding episodes in patients with haemophilia A.
- Gevalka (ensartinib) for the treatment of adult patients with anaplastic lymphoma kinase positive advanced non-small cell lung cancer.
- Klygefa (gefurulimab) for the treatment of adult patients with generalised myasthenia gravis.
- Lifyorli (relacorilant) for the treatment of platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer.
- Povofortay (povorcitinib) for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults.
- Sepalna (senaparib), a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube or primary peritoneal cancer.
- VaxRabeo (rabies virus (inactivated) strain WISTAR (PM/WI38 1503-3M)), a vaccine for pre-exposure and post-exposure prophylaxis against rabies in individuals of all age groups.
- Zeydovio (glepaglutide) for the treatment of short bowel syndrome
Two biosimilar medicines received a positive review:
- Adcomfo (omalizumab) for the treatment of asthma, chronic rhinosinusitis with nasal polyps and chronic spontaneous urticaria.
- Pebrilzo (pertuzumab), for the treatment of breast cancer in adults. Pebrilzo is the first biosimilar medicine recommended for approval following the tailored clinical approach.
Two generic medicines were also recommended:
- Inijaq (tofacitinib) for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis in adults, and juvenile idiopathic arthritis in children from two years of age.
- Ruxolitinib Zentiva (ruxolitinib) for the treatment of myelofibrosis in adults, polycythaemia vera in adults, and graft-versus-host disease in adults and children.
The CHMP recommended a change to the terms of the marketing authorisation for the medicinal product Anzupgo, used to treat moderate to severe chronic hand eczema in adults. The committee recommended lowering the age of administration to adolescents 12 years of age and older.
The committee also extended the indications for another 10 medicines that are already authorised in the European Union (EU): Abiraterone Mylan, Cosentyx, Enhertu, Jyseleca, Keytruda, Ocrevus, Padcev, Pepaxti, Sogroya, and Tecvayli.
