Biogen Idec Retools After FDA Clears Drug but Not Its Moniker
It seemed as if the Food and Drug Administration liked everything about Biogen Idec's new drug for multiple sclerosis.
Early this year, the FDA encouraged Biogen Idec and its partner, Elan Pharmaceuticals, to submit an application for approval a year ahead of schedule. The companies sought clearance based on one year of data from a pair of pivotal clinical trials, instead of two years, as originally planned. The agency said it would give the experimental drug priority review, cutting four months off the wait for an answer.
The agency's Nov. 23 ruling gave the companies the go-ahead to sell the drug as a stand-alone therapy or in combination with Avonex, Biogen Idec's big-selling MS drug.
Wall Street analysts called the dual approval a home run.
But there was one thing the regulators didn't like about the new drug: the name.
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Merry Christmas :-)
Posted by: Carrie at Dec 25, 2004 2:59:12 PM