FDA Accepts Application for Genentech Crovalimab for 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 hemoglobinuria (PNH)
• If approved, crovalimab will be the first monthly subcutaneous treatment for PNH, with the option to self-administer outside of a supervised healthcare setting
• Filing applications have also been accepted in the EU, China and Japan, and submissions to other regulatory authorities around the world are ongoing

https://www.biospace.com/article/releases/fda-accepts-application-for-genentech-s-crovalimab-for-the-treatment-of-pnh-a-rare-life-threatening-blood-condition/