Benzinga | Jan 11, 2021 07:35AM EST

Cytokinetics Granted Orphan Drug Designation for CK-3773274 for the Treatment of Hypertrophic Cardiomyopathy

Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to CK-3773274 (CK-274) for the treatment of symptomatic hypertrophic cardiomyopathy (HCM). CK-274 is a next-generation cardiac myosin inhibitor in development for the potential treatment of HCM.

The FDA, through its Office of Orphan Products Development (OOPD), grants orphan status to drugs and biologic products that are intended for the safe and effective treatment, diagnosis, or prevention of rare diseases or conditions that affect fewer than 200,000 people in the United States. Orphan drug designation provides a drug developer with certain benefits and incentives, including a seven-year period of U.S. marketing exclusivity from the date of marketing authorization, waiver of FDA user fees, and tax credits for clinical research.

"We're pleased that CK-274 received orphan drug designation from the FDA for symptomatic HCM encompassing both obstructive and non-obstructive presentations." said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President of Research & Development. "It's a promising time to develop investigational medicines for patients with HCM who currently have no FDA approved medical therapy available to treat the underlying hypercontractility associated with their disease. We believe treatment with CK-274 may represent a novel approach that may significantly impact patient function and quality of life. We look forward to results from REDWOOD-HCM, our ongoing Phase 2 clinical trial, expected mid-year."