FDA approves Rituxan-corticosteroid combination for Wegener's Granulomatosis and Microscopic Polyangiitis

Apr 20 2011

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) and Biogen Idec (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).

“For the first time, people with Wegener's Granulomatosis and Microscopic Polyangiitis have a medicine that the FDA has approved for the treatment of these rare and relapsing diseases”

WG and MPA are two severe forms of vasculitis called ANCA-Associated Vasculitis (AAV), a rare autoimmune disease that largely affects the small blood vessels of the kidneys, lungs, sinuses, and a variety of other organs. Both WG and MPA are considered orphan diseases with an estimated prevalence in the United States of approximately three cases per 100,000 people.

"For the first time, people with Wegener's Granulomatosis and Microscopic Polyangiitis have a medicine that the FDA has approved for the treatment of these rare and relapsing diseases," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "We are committed to following the science and focusing on diseases of high unmet medical need, including orphan conditions. Today's approval is an important example of how the scientific community can work together to advance science and treatment options for orphan diseases."

The approval is based on a National Institutes of Health-sponsored study known as RAVE (Rituxan in ANCA-Associated Vasculitis). The study showed that Rituxan was not inferior to the current standard of care, cyclophosphamide (CYC) in inducing disease remission at six months in adults with WG and MPA.