FDA accepts application for Roche ’s crovalimab for the treatment of PNH, a rare life-threatening blood condition

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 (PNH)1If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare settingFiling applications have also been accepted in the EU, China and Japan, andsubmissions to other regulatory authorities around the world are ongoingBasel, 6 September 2023 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s Biologics License Application (BLA) for crovalimab, an investigational, novel anti-C5 recycling monoclonal antibody, for the treatment of paroxysmal nocturnal haemoglobi nuria (PNH). The acceptance was based on results from the pivotal phase III COMMODORE 2 study, which demonstrated that in people with PNH, crovalimab achieved disease control and was well-tolerated.1 Results from the phase III COMMODORE 1 study, demonstrating the consistent benefit-risk profile of crovalimab, also supported the application.2“This filing acceptance reinforces the value of crovalimab, which was engineered to be recycled in the bloodstream with the goal of offering a sustained response while reducing treatment burden,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Developm ent. “Crovalimab could provide an ...
Source: Roche Investor Update - Category: Pharmaceuticals Source Type: news