EMA backs 12 new medicines, alongside key label expansions

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended 12 new medicines for approval at its September 2026 meeting, while backing extensions of indication for 11 existing medicines.

Among the new medicines, the CHMP recommended Novo Nordisk’s Frehemgo (denecimig) for preventing bleeding episodes in people with haemophilia A.

“The recommendation by the CHMP for approval of Frehemgo builds on Novo’s commitment of over 40 years in haemophilia and marks an important advancement for people living with haemophilia A,” said Novo Nordisk president and CEO Mike Doustdar. “The combination of strong bleed protection, flexible dosing frequency and a prefilled pen offers a differentiated treatment option that can reduce treatment burden and give people with haemophilia A greater freedom in managing their disease.”

Other positive opinions included SFL Pharmaceuticals’ Gevalka (ensartinib) for ALK-positive advanced non-small cell lung cancer and Sepalna (senaparib) for maintenance treatment of certain advanced ovarian, fallopian tube and primary peritoneal cancers.

Alexion’s Klygefa (gefurulimab) was backed for generalised myasthenia gravis, while Corcept Therapeutics’ Lifyorli (relacorilant) received a positive opinion for platinum-resistant ovarian, fallopian tube or primary peritoneal cancer. Incyte’s Povofortay (povorcitinib) was recommended for moderate-to-severe hidradenitis suppurativa.

The CHMP also backed VaxRabeo, Sanofi’s rabies vaccine, and Zeydovio (glepaglutide) for adults with short bowel syndrome. 

Biosimilars Adcomfo (omalizumab) and Pebrilzo (pertuzumab), as well as generics Inijaq (tofacitinib) and Ruxolitinib Zentiva (ruxolitinib), completed the 12 recommendations.

Extended indications

Among 11 recommended indication extensions, Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan) received CHMP backing in early-stage HER2-positive breast cancer.

“This positive CHMP opinion marks a significant step towards bringing Enhertu into early-stage HER2-positive breast cancer in the EU,” said AstraZeneca oncology R&D executive vice president Susan Galbraith. “Enhertu cut the risk of disease recurrence by more than half compared to adjuvant standard of care for patients with residual disease, and if approved could redefine post-surgery care in the EU, keeping patients disease-free for longer and increasing the potential for cure.”

The committee also recommended expanding Roche’s Ocrevus (ocrelizumab) to patients aged 10 years and older with relapsing forms of multiple sclerosis. Roche chief medical officer Levi Garraway said the opinion brings Europe “closer to bridging a longstanding gap” in treatment for young people with MS.

Pediatrician-in-Chief and Co-Director, Johns Hopkins Children’s Center. “Extending Ocrevus, a proven treatment for adults, to younger patients is an important step forward to suppress disease activity early on, with the goal of preserving their physical and cognitive health."

Meanwhile, Novo Nordisk’s Sogroya (somapacitan) was recommended as a once-weekly treatment for children with idiopathic short stature and persistent growth disturbance. If authorised, Novo said it would become the first growth hormone treatment approved specifically for idiopathic short stature in the EU.

Elsewhere, applications for Isembyld (apitegromab) and Zinmyleo (trilaciclib) were withdrawn, while extension applications for Alhemo, Kaftrio and Kalydeco were also withdrawn. The CHMP additionally confirmed, following re-examination, its recommendation to refuse marketing authorisation for Xervyteg, which was being developed for acute graft-versus-host disease.

The full CHMP recommendations.