Cytokinetics announces PDUFA action date for aficamten

Cytokinetics (CYTK) announced that the FDA has extended the Prescription Drug User Fee Act action date for the new drug application for aficamten for the treatment of patients with obstructive hypertrophic cardiomyopathy to December 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. Following pre-NDA discussions with 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 of Cytokinetics by FDA.