Sales of Drug for MS Resume
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Doctors have started prescribing the Tysabri multiple sclerosis drug for the first time in the U.S. since sales were suspended more than a year ago, the drug’s makers, Biogen Idec Inc. and Elan Corp., said Monday.
Tysabri, which was withdrawn in February 2005 because of links to a rare and fatal brain disease, received U.S. regulatory approval June 5 to return to the market.
In clearing resumed sales, the Food and Drug Administration mandated strict measures to monitor Tysabri’s side effects. Patients must be in a registry and sign a consent form. Doctors and other health professionals must also be trained and registered. Biogen said it expected to register about 2,500 physicians and 2,000 sites in the U.S. in its Tysabri safety program.
“Last week we began receiving enrollment forms and began dosing patients,” Biogen spokeswoman Amy Brockelman said.
Biogen shares rose 47 cents to $41.20, while Elan gained 12 cents to $13.43.
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