Opinion ID: 203426
Heading Depth: 2
Heading Rank: 3

Heading: Withdrawal of TYSABRI from the Market

Text: At approximately noon on February 18, 2005, roughly three months after TYSABRI was granted FDA approval, Biogen senior officers attended a meeting where they learned that two patients taking TYSABRI in the clinical trials had contracted PML, one of whom had died. Ten days later, on February 28, 2005, Biogen and Elan suspended all clinical trials and withdrew TYSABRI from the market. [5] In a press release, Biogen announced to the public that two patients had contracted PML, one of the two had died, and the decision to withdraw TYSABRI was made in consultation with [the] U.S. Food and Drug Administration (FDA). [6] On March 30, 2005, Biogen announced that a patient in the Crohn's disease trial who died in 2003 had been misdiagnosed with brain cancer, and in fact had died from PML. [7] The stock market reacted strongly to the withdrawal of the drug from the market. On February 28, Biogen's stock price dropped from $67.28 to $38.65, a 42.5% drop. Some 118 million shares were traded, more than thirty times the average daily trading volume during the class period.