India, Sept. 17 -- Novo Nordisk A/S (NVO) announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for FREHEMGO (denecimig) for the treatment of haemophilia A, with or without inhibitors, in adults and children.
FREHEMGO is a next-generation factor VIIIa mimetic bispecific antibody designed for routine prophylaxis to prevent or reduce bleeding episodes in people with haemophilia A.
The CHMP recommendation is based on the FRONTIER clinical trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualized bleeding rates compared with prior clotting factor prophylaxis and on-demand treatment in people with ha...