Quoted from http://www.bloomberg.com/apps/news?pid=20601202&sid=aCLgmEYb78tM
Biogen, Elan’s Drug Linked to 24 PML Cases, 4 Deaths
By Trista Kelley
Oct. 29 (Bloomberg) -- Biogen Idec Inc.’s multiple sclerosis drug Tysabri, jointly sold with Elan Corp., has been linked to four deaths by the European Medicines Agency.
The patients died of a deadly brain infection known as PML, and 24 cases of the disease have been diagnosed since Tysabri was reintroduced to the market in 2006, the European drug regulator said today in an e-mail. The U.S. Food and Drug Administration today confirmed the number of PML cases as 24 and declined to comment further. A call to Niamh Lyons, a spokeswoman for Dublin-based Elan, wasn’t immediately returned.
“We’re not commenting on individual cases of PML,” Jennifer Neiman, a Biogen spokeswoman, said today in a phone interview. “The incidence of PML is rare and the rate remains consistent with what was seen in clinical trials and what is described in our current label.”