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Thursday, October 18, 2012
FDA extends review of Biogen's multiple sclerosis drug
By Esha Dey | Reuters
(Reuters) - Biotechnology company Biogen Idec Inc said U.S. health regulators extended by three months the review date of its much-awaited multiple sclerosis (MS) drug BG-12, but analysts said the delay was only a minor setback.
Shares of Biogen were down 2 percent at $150.72 in morning trading on the Nasdaq.
The stock has risen more than 50 percent over the past 12 months, largely on optimism about BG-12, which showed robust results in trials and had no safety concerns.
Analysts said the delay would push the review date to March, but added such extensions were not uncommon.
"The registrational studies for BG-12 - DEFINE and CONFIRM - enrolled about 1,200 and 1,400 patients, respectively. Given the size and complexity of the filings, we are not surprised that the FDA would require additional time to review the application," Barclays Capital analyst Anthony Butler said.
The U.S. Food and Drug Administration said it needed additional time to review the application, but did not ask for additional studies, according to Biogen.
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