Benzinga | Dec 9, 2021 09:46PM EST

Cytokinetics Announces Receipt Of Breakthrough Therapy Designation From FDA for Aficamten

Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Aficamten is a next-generation cardiac myosin inhibitor in development for the potential treatment of HCM.



Breakthrough Therapy Designation is granted by FDA to expedite the development and review of drugs that are intended to treat a serious condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on a clinically significant endpoint. A drug that receives Breakthrough Therapy Designation is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program, and organizational commitment involving senior managers.

"We are pleased that the FDA has granted Breakthrough Therapy Designation for aficamten for the treatment of symptomatic oHCM, a disease associated with myriad symptoms and functional limitations," said Fady I. Malik, M.D., Ph.D., Cytokinetics' Executive Vice President of Research & Development. "The results of REDWOOD-HCM met our high expectations supporting the potential role of aficamten as an innovative therapy to address the hypercontractility that underlies oHCM. With start-up activities underway in SEQUOIA-HCM, our Phase 3 clinical trial of aficamten, we look forward to its further development and engaging with FDA as may hopefully benefit patients whose lives are severely impacted by this disease."