Here are the facts! While the first study showed the drug (Myotrophin) was effective in treating Lou Gehrig's disease, the second trial did not confirm the results. Now what? Are you going to say it is a conspiracy?
FDA Panel To Review Cephalon/Chiron's Myotrophin NDA May 8
Dow Jones News Service -- March 24, 1997
WEST CHESTER, Pa. (Dow Jones)-- Cephalon Inc. (CEPH) and Chiron Corp. (CHIR) said the Food and Drug Administration scheduled their new drug application for Myotrophin injection for review by the FDA's Peripheral and Central Nervous System Drugs Advisory Committee on May 8.
Cephalon and Chiron submitted the NDA on Feb. 11 for clearance to market the drug in the U.S., the companies said in a press release Monday.
As reported, Chiron and Cephalon are jointly developing myotrophin to treat Lou Gehrig's disease. The companies will equally split sales of the drug.
The Feb. 11 application contained data from two pivotal trials conducted with myotrophin on about 450 patients. New data was included as well, concerning long-term survival and levels of myotrophin, the name of insulin-like growth factor-1, in the blood.
While the first study showed the drug was effective in treating Lou Gehrig's disease, the second trial did not confirm the results.
Chiron Corp., Emeryville, Calif., is a healthcare company.
Cephalon is a biopharmaceutical company. |
