Amsterdam: The latest EMA CHMP recommendations, published at the European Medicines Agency’s headquarters on the Zuidas on 18 September 2026, cleared twelve new medicines for European approval and backed wider use of eleven more. The Committee for Medicinal Products for Human Use met from 14 to 17 September, and its output offers a useful snapshot of where European pharmaceutical regulation is putting its weight this autumn: rare diseases, oncology, and a biosimilar pathway that the agency hopes will lower the cost of copying complex biologics.
The headline opinion went to Frehemgo, Novo Nordisk’s denecimig, a factor VIIIa mimetic for preventing bleeding episodes in people with haemophilia A. Alongside it the committee endorsed Klygefa, Alexion’s gefurulimab for adults with generalised myasthenia gravis, and Zeydovio, glepaglutide for short bowel syndrome, a condition in which the gut can no longer absorb enough nutrients and fluid. Povofortay, Incyte’s povorcitinib, received a positive opinion as the first once-daily oral treatment for moderate to severe hidradenitis suppurativa in adults who have failed or cannot tolerate anti-TNF therapy.
Cancer care accounts for a large share of the September list. The committee recommended Gevalka, ensartinib, for ALK-positive advanced non-small cell lung cancer, and two new options in gynaecological oncology: Lifyorli, relacorilant combined with nab-paclitaxel for platinum-resistant ovarian, fallopian tube or primary peritoneal cancer, which carries orphan designation, and Sepalna, senaparib, as maintenance therapy for advanced high-grade disease. Sanofi’s VaxRabeo, an inactivated rabies vaccine for pre-exposure and post-exposure use in every age group, completed the set of new active substances.
The most consequential item for health budgets may be the least eye-catching. Pebrilzo, a pertuzumab biosimilar for breast cancer, is the first biosimilar the agency has recommended under its tailored clinical approach, which allows developers to rely more heavily on analytical and pharmacological comparison and less on large confirmatory trials. A second biosimilar, Adcomfo, copies omalizumab for asthma, nasal polyps and chronic urticaria, while generic versions of tofacitinib from Gedeon Richter and ruxolitinib from Zentiva also passed.
Among the eleven extensions of indication, Leo Pharma’s Anzupgo was cleared for adolescents aged twelve and over with chronic hand eczema, and established products including Keytruda, Enhertu, Ocrevus and Tecvayli gained new uses. Not every file advanced. Two initial applications were withdrawn, Scholar Rock’s apitegromab for spinal muscular atrophy and Pharmacosmos’s trilaciclib, and the committee confirmed on re-examination its refusal of Xervyteg, a pooled faecal microbiota product intended for acute graft-versus-host disease. Three other applicants refused in July have asked for their negative opinions to be re-examined.
Taken together, the September EMA CHMP recommendations bring the committee’s tally of positive opinions on new medicines to 66 so far in 2026, against eight negative opinions. The opinions now pass to the European Commission, which normally adopts legally binding marketing authorisations within about two months, after which national pricing and reimbursement bodies decide how quickly patients in each member state actually receive the products.
That final step is where the gap between approval and access tends to open. A single EU authorisation covers 27 markets, but launch sequencing by manufacturers and the pace of health technology assessment still leave patients in smaller or lower-income member states waiting longer. The new joint clinical assessment procedure under the EU Health Technology Assessment Regulation, which already applies to cancer medicines and advanced therapies, is meant to narrow that gap, and several of this month’s EMA CHMP recommendations in oncology will be among the files that test whether it does.
