Cephalon Myotrophin NDA filing is based on two clinical trials previously discussed by FDA committee.

Executive Summary

CEPHALON MYOTROPHIN NDA FILED FEB. 11 FOR AMYOTROPHIC LATERAL SCLEROSIS (Lou Gehrig's disease) based on the two pivotal trials previously reviewed by FDA's Peripheral & Central Nervous System Drugs Advisory Committee in June as part of the company's request for a Treatment IND. At the time, FDA and the committee agreed that Cephalon's second trial, conducted in Europe, failed to confirm the results of the first. Members of the committee suggested that an additional trial would be required for the application to be approved ("The Pink Sheet" June 17, 1996, p. 9).