Biogen Idec, Roche get OK for new drug use

Bloomberg News / January 29, 2011

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Roche Holding AG and Biogen Idec Inc. won expanded US approval for use of the Rituxan medicine against a common form of blood cancer.

The Food and Drug Administration authorized the use of Rituxan as a follow-up therapy in patients with advanced follicular non-Hodgkin’s lymphoma who have received an initial primary treatment, the companies said yesterday.

Rituxan, also called MabThera, won European approval in October for the same patients.

The medicine is approved for use in rheumatoid arthritis, chronic lymphocytic leukemia, and non-Hodgkin’s lymphoma.

The drug generated $1.61 billion in revenue for Basel, Switzerland-based Roche during the third quarter and $258 million for Weston, Mass.-based Biogen Idec, the companies said.

Results of a study released in May showed that among follicular lymphoma patients given follow-up therapy with Rituxan for two years, 82 percent had no worsening of their condition compared with 66 percent of those who didn’t get maintenance doses.