Thursday, April 19, 2012

Cytokinetics ALS drug wins 'fast track' designation

Cytokinetics Inc.’s experimental drug to treat patients with amyotrophic lateral sclerosis, or Lou Gehrig’s disease, won fast-track designation from the Food and Drug Administration, the company said Thursday.
The drug, CK-2017357, is only in Phase II, but the fast-track status makes the drug eligible for a rolling review of a new drug application, accelerated approval and more frequent meetings with the FDA, all of which could shave months off the approval process.

No comments:

Post a Comment