European drug regulators just wrapped another stack of reviews, and the EU bloc now has a sizeable list of likely new treatments to show for it.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has signed off on eight new medicines, two biosimilars and two generics, while also recommending label extensions for 11 other therapies.
Among the most notable developments is a positive recommendation for Novo’s Frehemgo, also known as denecimig, to treat or prevent bleeding episodes in adults and children with hemophilia A.
Novo is positioning the drug as a next-generation factor VIIIa mimetic. The bispecific antibody works by binding Factor IXa and Factor X to increase thrombin production and improve clotting. Frehemgo is in direct competition with Roche’s blockbuster and current market leader Hemlibra, which made 4.8 billion Swiss francs ($5.81 billion) in sales last year.
The CHMP recommendation comes just days after Frehemgo’s first approval in Saudi Arabia and makes way for a possible approval from the European Commission in the coming weeks. It’s a welcome win for Novo after suffering a string of late-stage disappointments in its cardiovascular pipeline amid mounting competition in metabolic medicine markets.
The Danish drugmaker expects an initial launch of Frehemgo by years' end, with a broader rollout in early 2027.
AstraZeneca’s rare disease business Alexion also snagged a recommendation from the CHMP, setting up dual-binding nanobody C5 inhibitor Klygefa for a formal approval from the EC. Klygefa, also known as gefurulimab, received the CHMP go-ahead as a treatment for adult patients with generalized myasthenia gravis (gMG), a chronic autoimmune disease marked by muscle weakness caused by the immune system’s attack on the connection points between the nerves and muscles.
The treatment marks AstraZeneca’s continued investment in the C5 inhibitor class after Soliris and Ultomiris. But unlike those earlier infused drugs, Klygefa is a self-administered injection, offering patients more control and flexibility. If approved, Europe will be Klygefa’s second approval after Japan earlier this month and it will be the first dual-binding nanobody C5 inhibitor approved for gMG patients.
Beyond those meds, new offerings from SFL Pharmaceuticals, Corcept, Incyte Biosciences and Sanofi also made the cut at CHMP this week. SFL scored double with a positive recommendation for both Gevalka and Sepalna. Gevalka was recommended in adults with anaplastic lymphoma kinase-positive advanced non-small cell lung cancer, a version of the disease more common in young patients who have never smoked. And Sepalna was recommended as a maintenance treatment of advanced epithelial high-grade ovarian, fallopian tube, or primary perineal cancer.
Corcept’s Lifyorli, meanwhile, snagged a recommendation as a combo treatment with chemotherapy for platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer. Incyte Biosciences’ Povofortay will take a positive review to the European Commission for acne inversa. And rounding out the list of endorsements was Sanofi’s rabies vaccine VaxRabeo.
Alfasigma’s Jyseleca, AstraZeneca and Daiichi Sankyo's Enhertu, Merk & Co.'s Keytruda, Novartis’ Cosentyx, Leo’s Anzupgo, and Roche’s Ocrevus, among others, took positive opinions for their proposed label expansions.
In a setback for MaaT Pharma, the CHMP elected—after reexamination—to uphold its decision to recommend against Xervyteg as a treatment for acute graft-versus-host disease, a life-threatening condition in which donor bone marrow or stem cells attack the patient. The agency maintained that MaaT’s single-arm trial did not show a sufficient benefit-risk profile. In response, the pharma proposed a phase 3 trial evaluating Xervyteg against a best available therapy to satisfy regulator concerns.
All CHMP recommendations now head for the European Commission for final sign-off.