Novo Nordisk (NYSE: NVO), a Danish pharmaceutical company, has been notified that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Alhemo (concizumab). This would make Alhemo the first once-daily subcutaneous prophylactic treatment for individuals aged 12 years or older with haemophilia A or B who have inhibitors.
Alhemo, an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody (mAb), functions by blocking the protein TFPI, which normally prevents blood from clotting. By inhibiting TFPI, Alhemo aids in blood clotting and prevents bleeding episodes, even in the presence of missing or deficient clotting factors.
The drug is already registered in Australia and Switzerland for the treatment of adolescents and adults (12 years or older) with haemophilia A or B with inhibitors. In Japan, Alhemo is used to treat adolescents and adults (12 years or older) with haemophilia A or B, both with and without inhibitors. It is also indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
The positive recommendation from the CHMP highlights the potential for Alhemo to provide a new standard of care for individuals living with haemophilia A or B and inhibitors across Europe.- Flcube.com
