Posted by Michael Wonder on 06 Sep 2023
FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition
6 September 2023 - Acceptance based on the Phase III COMMODORE 2 study, which demonstrated crovalimab achieved disease control and was well-tolerated in people with paroxysmal nocturnal haemoglobinuria.
Genentech announced today that the US FDA has accepted the company’s biologics license application for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal haemoglobinuria.
