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EU CHMP adopts positive opinion recommending marketing authorization for FREHEMGO to treat haemophilia A
NONOFNovo Nordisk A S
On September 17, 2026, Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for FREHEMGO® (denecimig) in the EU. This next-generation factor VIIIa mimetic bispecific antibody is indicated for treating haemophilia A with or without inhibitors in adults and children, offering flexible dosing frequencies of once monthly, every two weeks, or weekly via a pre-filled pen. The recommendation is based on the FRONTIER trial programme, which demonstrated significantly reduced annualised bleeding rates and no new safety signals compared to prior treatments. Novo Nordisk expects to launch FREHEMGO® in select European countries in Q4 2026, with broader EU availability starting early 2027. This regulatory milestone represents a significant advancement for the company's haemophilia franchise and potential revenue growth. Novo Nordisk operates in the pharmaceutical industry, developing treatments for diabetes, obesity, rare diseases, and other serious conditions.