FDA approves Rituxan for pemphigus vulgaris

FDA approved Genentech Inc.’s Rituxan rituximab to treat moderate to severe pemphigus vulgaris. The Roche (SIX:ROG; OTCQX:RHHBY) unit said Rituxan is the first biologic approved by the agency for the disease and the first FDA-approved treatment for the indication in more than 60 years.

The chimeric mAb against CD20 antigen has breakthrough therapy and Orphan Drug status from FDA for the indication.

Genentech and Biogen Inc. (NASDAQ:BIIB) co-market IV Rituxan in the U.S., where it is also approved to treat chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), diffuse large B cell lymphoma (DLBCL), rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis.

Roche markets IV and subcutaneous formulations of rituximab in the EU as MabThera.