Myotrophin NDA Filed In The USA
Cephalon and Chiron have filed for approval of Myotrophin (mecasermin;insulin-like growth factor-1) in the USA for the treatment of amyotrophic lateral sclerosis. The companies are now preparing applications for Canada and Europe.
Two Phase III trials of the drug produced positive but somewhat divergent results, leading to speculation that the firms may need to conduct another trial to secure approval (Marketletters passim). Despite this, they have pressed ahead, putting the ball in the court of the Food and Drug Administration.
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