Myotrophin Up Against FDA Panel Again
Cephalon and Chiron were due to meet with the US Food and DrugAdministration's Central Nervous System Drugs Advisory Committee on May 8 (after the Marketletter went to press), in a second attempt to get Myotrophin (mecasermin) recommended for approval to treat amyotrophic lateral sclerosis.
When the panel last met in June 1996, no formal vote on the application was taken, but some members of the panel suggested that the company conduct additional trials before submitting its New Drug Application, as the two trials already conducted had contradictory results (Marketletters passim). The company said that it was unwilling to do another study and submitted the NDA. Follow-up data have since shown that the two studies taken together support Myotrophin's safety and efficacy.
Cephalon said it would present the panel with new information, including a survival analysis and pharmacokinetics that links blood levels of the drug with efficacy.
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