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Cytokinetics Announces Receipt of Breakthrough Therapy Designation from FDA for Aficamten
FDA Granted Designation for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy Based on Results of REDWOOD-HCM SOUTH SAN FRANCISCO, Dec. 09,
About this update from Cytokinetics, Incorporated
[{"type":"text","content":"FDA Granted Designation for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy Based on Results of REDWOOD-HCM\nSOUTH SAN FRANCISCO, Dec. 09, 2021 (GLOBE NEWSWIRE) -- 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.” About REDWOOD-HCM The Breakthrough Therapy Designation for aficamten was based on results from Cohorts 1 and 2 of REDWOOD-HCM (Randomized Evaluation of Dosing With CK-274 in Obstructive Outflow Disease in HCM), the Phase 2 clinical trial of aficamten in patients with symptomatic oHCM, which were presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in September 2021. The results showed that treatment with aficamten for 10 weeks resulted in statistically significant reductions from baseline compared to placebo in the average resting left ventricula...