Friday, March 21, 2008

Biogen's Tysabri to get liver warning in Europe

Thursday, March 20, 2008 - 2:57 PM EDT

On the heels of a similar decision by the U.S. Food and Drug Administration, European regulators have concluded that patients should be warned about possible liver damage related to the Biogen Idec drug Tysabri.

Tysabri, which Massachusetts-based Biogen Idec (Nasdaq: BIIB) makes at a facility in Research Triangle Park, is a drug used to treat multiple sclerosis.

On Feb. 27, Biogen and its Irish partner on Tysabri, Elan Corp., posted a letter to the FDA's Web site. The letter, addressed to doctors, says patients have developed signs of liver injury as soon as six days after taking their first dose of the drug. It tells doctors that they need to monitor Tysabri patients for potential liver damage and warn them about the risk.

Now, the European Medicines Agency is addressing the issue. In a statement Thursday, it also says that Tysabri patients need to be monitored for and warned about liver damage.

Tysabri is Biogen's fastest-growing drug. It was pulled from the market in 2005 after it was linked to a rare but fatal brain infection. U.S. regulators allowed it to return under a monitoring program in 2006, however, after they decided that the drug's effectiveness outweighed its risks.