FDA Pushes Potential Approval For Cytokinetics' Experimental Heart Drug By Three Months
The U.S. Food and Drug Administration (FDA) on Thursday extended the Prescription Drug User Fee Act (PDUFA) action date for the New Drug Application (NDA) for Cytokinetics Inc's (NASDAQ:CYTK) aficamten for patients with obstructive hypertrophic cardiomyopathy (oHCM) to December 26 from September 26.
The FDA recently notified Cytokinetics that additional time is required to conduct a full review of the company's proposed Risk Evaluation and Mitigation Strategy (REMS).
Also Read: Bristol Myers Analyst Says FDA Update Is A Win For Camzyos With Simpler Use, Broader Reach
Following pre-NDA discussions with the FDA in which safety and risk mitigation were discussed, Cytokinetics submitted the NDA for aficamten in oHCM without an accompanying REMS, and the FDA accepted the NDA for filing.
Recently, during the NDA review, the FDA requested that Cytokinetics submit a REMS, based on the inherent characteristics of aficamten, which the company provided.
The submission of a REMS has now been determined by FDA to be a Major Amendment to the NDA resulting in a standard three-month extension to the original PDUFA action date.
No additional clinical data or studies have been requested on Cytokinetics by the FDA.
"We remain confident in the distinct benefit-risk and pharmaceutic profile of aficamten and continue to expect a differentiated label and risk mitigation profile upon its potential approval by FDA," said Robert I. Blum, Cytokinetics' President and Chief Executive Officer. "
In April, Bristol Myers Squibb & Co (NYSE:BMY) released topline data from the Phase 3 ODYSSEY-HCM trial of Camzyos (mavacamten) for symptomatic New York Heart Association (NYHA) class II-III non-obstructive hypertrophic cardiomyopathy (nHCM).
The trial did not meet its dual primary endpoints of changes from baseline to Week 48 compared to placebo in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2).
In January, a Stifel analyst wrote that Cytokinetics appears well-positioned to capitalize on Bristol Myers' groundwork with its second-to-market drug, Alicante, which is expected to have a best-in-class profile. There is a strong case for aficamten to secure a differentiated REMS, potentially including six-month echocardiograms (Q6M echos) as a standard.
Price Action: CYTK stock is down 16.5% at $35.85 at the last check Friday
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