FDA Sets June 7 Review Of Cephalon/Chiron's Myotrophin
WEST CHESTER, Pa. (Dow Jones)--Cephalon Inc. (CEPH) and its partner, Chiron Corp. (CHIR), said the U.S. Food and Drug Administration has scheduled Myotrophin (rhIGF-1) for review by its Peripheral and Central Nervous System Drugs Advisory Committee on June 7.
The companies said will present findings from two completed clinical studies which evaluated Myotrophin's utility in treating amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease).
Data from these studies have been submitted to the FDA in support of a Treatment Investigational New Drug application, they noted.
The companies plan to submit a New Drug Application (NDA) based upon these studies later this year for clearance to market the drug in the U.S.
Chiron Corp., Emeryville, Calif., is a science-driven healthcare company that combines diagnostic, vaccine and therapeutics strategies for controlling disease.
Cephalon discovers, develops and markets pharmaceutical products for the treatment of neurological disorders.
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