FDA has accepted Genentech’s Biologics License Application (BLA) for crovalimab to treat paroxysmal nocturnal hemoglobinuria (PNH). The BLA acceptance was based on the recent phase 3 COMMODORE 2 study (NCT04434092) and the phase 3 COMMODORE 1 trial (NCT04432584), in which crovalimab showed better disease control and was well-tolerated.
Crovalimab is a promising new monoclonal antibody targeting C5 recycling for treating PHN. The results from the COMMODORE 1 trial showed that when PHN patients were switched to crovalimab, their disease remained under control. Also, the treatment exhibited a risk-benefit profile consistent with findings from COMMODORE 2.
The Chief Medical Officer and head of Global Product Development at Genentech, Levi Garraway, M.D., Ph.D., stated in the press release that the BLA acceptance by the FDA highlights the value of crovalimab, designed to undergo recycling within the bloodstream, aiming to provide a long-lasting therapeutic effect while minimizing the demands of treatment. He added that people suffering from this lifelong condition will no longer have to visit the clinic multiple times as crovalimab can be self-administered infrequently every four weeks.
Crovalimab is currently under extensive clinical scrutiny as part of a comprehensive development program encompassing five active Phase III trials and three preceding-phase investigations focused on PNH and various other complement-mediated disorders.
Source: FDA accepts application for Genentech’s crovalimab for the treatment of PNH, a rare life-threatening blood condition.
https://www.gene.com/media/press-releases/15000/2023-09-04/fda-accepts-application-for-genentechs-c
