Cephalon/Chiron Myotrophin review goal date is Nov. 11 after submission of NDA amendment.
Executive Summary
CEPHALON MYOTROPHIN REVIEW GOAL DATE SET FOR NOV. 11 following submission of an amendment by Chiron and Cephalon several weeks before the Aug. 11 priority review deadline for insulin-like growth factor for treatment of amyotrophic lateral sclerosis. The companies submitted the NDA for Myotrophin (mecasermin) on Feb. 11. The drug was not recommended for approval by the Peripheral & Central Nervous System Drugs Advisory Committee on May 8 ("The Pink Sheet" May 12, p. 7). The extension in the review deadline will buy some time for FDA. The agency has indicated that it believes another study is necessary to support approval; a rejection letter, however, would trigger a wave of unwelcome publicity for the agency with media coverage in the past month heavily focused on patients advocating approval of the agent.