Wednesday, February 27, 2008

Biogen warns of liver damage risk from Tysabri

Cambridge biotech Biogen Idec Inc. and its partner, Irish drug company Elan Corp. plc, issued a warning letter to clinicians about potential liver damage caused by the two firms' drug Tysabri.

The letter, posted on the U.S. Food and Drug Administration website Wednesday by Biogen (Nasdaq:BIIB), warns that "significant" liver injury was reported in patients as early as six days after taking Tysabri, and patients should be told the potential of liver damage from the drug.

Sandy Walsh, a spokeswoman for the FDA, said the warning letter contained updated prescribing information approved by the agency in January. Last month, the FDA approved the Tysabri as a treatment for a chronic inflammatory condition called Crohn's disease. The treatment was previously approved for patients with multiple sclerosis, another chronic inflammatory disease.

Biogen, which employs 4,300 workers worldwide, reported 2007 net income of $638.2 on revenue of $3.2 billion.