FDA OKs Roche's Rituxan for rare blood vessel inflammation diseases

Under Priority Review status, the FDA approves Roche (OTCQX:RHHBY +0.3%) unit Genentech's Rituxan (rituximab), combined with steroid hormones, for the treatment of children as young as two years old with granulomatosis with polyangiitis and microscopic polyangiitis, rare vasculitis disorders in which the small blood vessels become inflamed restricting blood flow.

Rituxan has Orphan Drug designation for the indication.

The CD20-directed cytolytic antibody was first approved in the U.S. in November 1997 for non-Hodgkin lymphoma. Today's approval is the ninth indication.

https://seekingalpha.com/news/3502404-fda-oks-roches-rituxan-rare-blood-vessel-inflammation-diseases