FDA approves costly autoimmune disease drug

Genentech and Biogen Idec announced April 19 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).

Both WG and MPA, forms of vasculitis, are considered extraordinary, orphan diseases with an estimated prevalence in the United States of approximately three cases per 100,000 people.

Rituxan® already is used to treat arthritis and cancer. The cost of a course of treatment with Rituxan® is approximately $5,000 to $80,000 with some insurance companies covering portions of the medical payments.

According to the Vascular Disease Foundation's website, "Vasculitis is an inflammation of the wall of a blood vessel, a tube that carries blood." This inflammation may result in vessel blockage and weakening of the vessel wall which could lead to an aneurysm and/or to hemorrhage or bleeding.

“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, in a press release.

“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.”

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), was named to Forbes' "400 Best Big Companies in America" List in its January 2008 issue. Biogen Idec stock is traded on the Nasdaq as BIIB.

©2011 Tomi Johnson. All rights reserved.