Swiss pharmaceutical giant Roche’s subsidiary, Genentech (SWX: ROG), has submitted its anti-C5 investigational drug, crovalimab, to the US Food and Drug Administration (FDA) for the treatment of the rare disease paroxysmal nocturnal hemoglobinuria (PNH). The filing is bolstered by Phase III clinical data that demonstrates crovalimab’s non-inferiority and a similar benefit-risk profile compared to AstraZeneca’s (AZ, NASDAQ: AZN) Soliris (eculizumab), which is currently the standard of care for PNH patients.
Crovalimab’s Patient-Friendly Treatment Regimen
Genentech’s monoclonal antibody (mAb) crovalimab offers a significant advantage over Soliris with its administration schedule. While Soliris requires bi-weekly treatment, crovalimab can be administered every four weeks, reducing the treatment burden for patients. This innovation is attributed to crovalimab’s design as a recycling mAb within the bloodstream, which enables sustained inhibition of the complement system, a critical factor in the destruction of red blood cells associated with PNH.
Global Filings and Broader Applications for Crovalimab
The company has indicated that similar filings for crovalimab are under review in other global markets, reflecting the drug’s potential to become a new standard of care for PNH. Additionally, crovalimab is being developed for other complement-mediated diseases, indicating its broad therapeutic potential beyond PNH.-Fineline Info & Tech
