Myotrophin Review Period Extended
The US Food and Drug Administration has said it is extending its reviewperiod for Myotrophin (mecasermin), the treatment for amyotrophic lateral sclerosis developed by US biotechnology firms Cephalon and Chiron, until November 11, 1997.
The review period was originally set to conclude this month, but the FDA has added the extra time in order to assess an ammendment to the New Drug Application recently filed by the two firms. Earlier this year, an FDA advisory panel issued a negative recommendation on the drug (Marketletters May 16 and 26).
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