The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended 12 new medicines for approval at its September 2026 meeting.
The CHMP also backed extensions of indication for 11 existing medicines, marking a busy round of endorsements from the regulatory body.
Among the headline approvals, Novo Nordisk’s Frehemgo, known chemically as denecimig, received a positive opinion for preventing bleeding episodes in people with haemophilia A.
Frehemgo is a next-generation factor VIIIa mimetic bispecific antibody, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with or without inhibitors.
The recommendation is based on the phase 3 FRONTIER programme, where denecimig achieved consistently low mean annualised bleeding rates, generally below 1, with many participants recording zero treated bleeds.
Novo Nordisk reported no new safety signals on switching from emicizumab, strengthening the case for Frehemgo as a compelling treatment option for haemophilia A patients.
Following the positive opinion, commercial launch of Frehemgo is expected in initial European countries in the fourth quarter of 2026, with broader EU availability planned for early 2027.
AstraZeneca also secured a significant CHMP win, with the committee blessing its novel cancer drug Etcamah with a positive opinion less than a month after a mixed FDA advisory committee outcome.
The FDA advisory committee voted 6-3 to recommend rejection of AstraZeneca’s treatment, with regulators arguing the study did not adequately demonstrate long-term benefit compared with waiting until disease progression to switch therapy.
Despite the FDA’s concerns over the clinical meaningfulness of a 6.8-month median progression-free survival extension recorded in the trial, European regulators took a more favourable view of camizestrant’s potential.
Novo Nordisk scored a second major CHMP endorsement at the same meeting, with the committee clearing its Wegovy pill for approval as the first oral GLP-1 treatment for obesity in Europe.
The oral Wegovy approval arrives at a competitive moment, as Eli Lilly gained approval in the United States last month for its own obesity pill, Foundayo, intensifying the race in the oral weight-loss drug market.
Novartis also received a CHMP nod for Vijoice, an oral drug treating the rare disorder known as PIK3CA-related overgrowth spectrum, covering patients aged 2 and older.
The European endorsement of Vijoice comes four years after the FDA approved the treatment, which is the first therapy of its kind to address the underlying cause of the condition.