Europe Drug Regulator's Advising Panel Recommends Approval Of Novo Nordisk's Australia-Approved Hemophilia Drug

On Friday, Novo Nordisk A/S (NYSE:NVO) said that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending approval of Alhemo (concizumab) as the first once-daily subcutaneous prophylactic treatment for hemophilia patients aged 12 years or older, with A or B with inhibitors.

Haemophilia is a rare bleeding disorder that impairs the body’s ability to make blood clots, a process needed to stop bleeding.

Also Read: Novo Nordisk’s Hemophilia Candidate Can Prevent Bleeding Episodes Effectively, Regardless Of Dosing Frequency.

Alhemo is an anti-tissue factor pathway inhibitor (TFPI) monoclonal antibody that, if approved by the European Commission, will offer the first once-daily subcutaneous prophylactic treatment to ...