Novo Nordisk announced on Thursday, September 17, 2026 that the EMA's CHMP recommended marketing authorization for FREHEMGO (denecimig) to treat hemophilia A, with or without inhibitors, in adults and children. Denecimig is a factor VIIIa-mimetic bispecific antibody that bridges factor IXa and factor X to mimic the cofactor function of activated factor VIII. Novo says it is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks, and once-weekly prophylaxis in a single-use pre-filled pen. The application was based on the FRONTIER2, FRONTIER3, and FRONTIER4 trials, and FRONTIER5 showed no new safety signals in patients switching from emicizumab. Pending a European Commission decision, Novo expects launches in the first European countries in Q4 2026 and across the EU starting early 2027.
Novartis announced on Friday, September 18, 2026 that the CHMP adopted a positive opinion for Cosentyx (secukinumab) to treat polymyalgia rheumatica (PMR) in adults who have had an inadequate response to steroids or who relapse during steroid taper. Novartis says Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR. The opinion is based on the global Phase III REPLENISH trial, run in 27 countries, in which all primary and secondary endpoints were met across both the 300 mg and 150 mg arms; Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, with no new safety signals. The data were published in the New England Journal of Medicine, and the European Commission is expected to decide within about two months.
Zealand Pharma announced on Friday, September 18, 2026 that the EMA's CHMP recommended approval of Zeydovio (glepaglutide) for short bowel syndrome. Zeydovio is a long-acting GLP-2 analog given twice weekly by subcutaneous injection from a ready-to-use, single-dose autoinjector. In the Phase 3 EASE-1 trial of 106 patients dependent on parenteral support, two thirds of patients on glepaglutide had at least a 20% reduction in weekly parenteral support volume at 24 weeks and one in seven weaned off it entirely; twice-weekly glepaglutide cut weekly parenteral support by 5.13 liters versus 2.85 liters on placebo. Zealand called the opinion the first major advance in short bowel syndrome treatment in Europe in more than a decade and expects a European Commission decision in about 67 days. In the U.S., the EASE-5 trial is ongoing, and glepaglutide has FDA orphan drug designation.
Merck announced on Friday, September 18, 2026 that the CHMP recommended approval of Keytruda (pembrolizumab) with Padcev (enfortumab vedotin) as neoadjuvant treatment, continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer; the recommendation also covers subcutaneous Keytruda. In the Phase 3 KEYNOTE-B15 (EV-304) trial, the regimen reduced the risk of an event-free survival event by 47% and the risk of death by 35% versus gemcitabine and cisplatin chemotherapy plus surgery, and the pathologic complete response rate was 55.8% versus 32.5%. Merck said it would be the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for muscle-invasive bladder cancer regardless of cisplatin eligibility in the EU. A European Commission decision is expected by the fourth quarter of 2026, and the FDA approved the combination for this use in July 2026. Merck's partners on the regimen are Astellas and Pfizer.