A new potential treatment on the horizon. I’m so excited!
Cytokinetics, Incorporated (Nasdaq: CYTK) announced today that its fast skeletal muscle troponin activator, CK-2017357, has been granted orphan-drug designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of amyotrophic lateral sclerosis (ALS), also commonly known as Lou Gehrig’s Disease. CK-2017357 is the lead drug candidate that has emerged from the company’s skeletal sarcomere activator program. Cytokinetics plans to initiate a Phase II Evidence of Effect clinical trial for CK-2017357 in ALS patients in the first half of 2010.
Orphan-drug designation is granted by the FDA Office of Orphan Drug Products Development to novel drugs or biologics that may treat a condition affecting less than 200,000 persons in the United States or occurs in more than 200,000 persons and for which there is no reasonable expectation that the cost of development and distribution of the drug will be recovered. The designation offers a number of potential incentives, which may include a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, funding for clinical studies, study design assistance, waiver of FDA user fees, and tax credits for clinical research.
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Very exciting indeed!
Good Luck