Biogen Inc. (NASDAQ:BIIB)
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5 Years : From Apr 2012 to Apr 2017
Biogen Idec Inc. (BIIB) has received a letter of deficiency from Health Canada for its application to sell the multiple sclerosis treatment fampridine in the country.
The Weston, Mass., biotech company also recently received questions from the European Medicines Agency on an application to sell the same drug in the region. Biogen expects a decision later this month. The disclosures were made at the JPMorgan healthcare conference in San Francisco Tuesday by Chief Executive George Scangos.
Scangos declined to comment on the letter or provide any further detail about the questions from the regulators.
Fampridine helps improve walking in multiple sclerosis patients and is sold in the U.S. by Acorda Therapeutics Inc. (ACOR) under the name Ampyra.
Separately, the company said that about 56,000 patients are using its MS drug Tysabri as of the end of December, an increase of 1,700 patients from fourth quarter and down from the 2,100 patients added in the third quarter.
-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; firstname.lastname@example.org