Biogen, Genentech score FDA OK for autoimmune disease drug

Biogen, Genentech score FDA OK for autoimmune disease drug

April 21st, 2011 // 1:34 pm @

A drug co-developed by Weston-based Biogen Idec Inc. and California-based Genentech has won approval by the U.S. Food and Drug Administration as part of a new treatment for Wegener’s Granulomatosis and Microscopic Polyangiitis, two rare and potentially fatal diseases.

Rituxan – a drug already FDA-approved to treat rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma – is now approved, in combination with corticosteroids, to treat the two orphan diseases, Wegener’s Granulomatosis and Microscopic Polyangiitis. These diseases, considered more severe forms of ANCA-Associated Vasculitis, impact small blood vessels of the lungs, kidneys, sinuses and other organs, and in the U.S., about three people per every 100,000 are afflicted with it.

Rituxan will serve as an alternate treatment to the currently available CYC chemotherapy treatment for the diseases. The FDA granted approval to Rituxan based on study results showing the drug had similar disease remission results at six months as CYC chemotherapy.

In December 2006, the FDA issued an alert noting that two patients taking Rituxan died from an infection of the central nervous system known as progressive multifocal leukoencephalopathy (PML). The patients were taking the drug to treat systemic lupus erythematosus, which is not an approved use of the drug.

In August 2010, Biogen (Nasdaq: BIIB) and Genentech were sued by a man who said he suffered an infection that left him paralyzed and said that Rituxan was to blame for making him more susceptible to such infections. He was taking the medication for thrombotic thrombocytopenic purpura, a rare blood disease. The drug is not approved for that indication.


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