Saturday, September 13, 2008
Genetech, Biogen Drug Related To Brain Disorder Death
The Food and Drug Administration reported, on Thursday, of the death of a woman who developed a rare brain disorder about 18 months after taking the final prescribed dosage of Genentech and Biogen Idec's Rituxan.
The FDA has advised the doctors to look for any neurological problems in patients taking Rituxan.
A company spokeswoman for Genentech remarked that the drug's label already states risks of the infection.
"The patient had a number of confounding factors that make it difficult to assess the potential role, if any, that Rituxan exposure may have played," said Tara Cooper. She further said that Genentech first disclosed the death during its July earnings call.
Rituxan, a blockbuster drug for arthritis and cancer, is marketed by Genentech and Biogen Idec in the U.S.
Both Rituxan and Tysabri multiple sclerosis drug, which reportedly also triggered the brain disorder in rare cases, are built on antibodies that maneuver the immune system.
FDA reported that the patient who died while on Rituxan had also received chemotherapy agents about nine months earlier.
Shares of Genentech Inc. rose $1.08 Thursday to $96.77 in afternoon trading. Shares of Biogen Idec Inc. fell 18 cents to $47.12.