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# FDA Extends Aficamten Review Over REMS Request
- URL: https://www.fdaweb.com/fda-extends-aficamten-review-over-rems-request/
- Published: 2025-05-01T12:00:00.000Z
- Updated: 2026-09-14T15:10:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159107

FDA has extended by three months its review of a Cytokinetics NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy (oHCM). The agency said the review extension is required to conduct a full review of the company’s proposed Risk Evaluation and Mitigation Strategy (REMS), according to the company.

“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,” the company says. “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 was considered a major amendment and the revised user fee review action target date is 12/25, it says, adding that no additional clinical data or studies have been requested.

The NDA submission is based on data from the Phase 3 SEQUOIA-HCM pivotal trial, which demonstrated that aficamten had a “positive impact on exercise capacity, clinical outcomes, symptom burden and cardiac biomarkers in patients with oHCM, with a consistent effect across all prespecified subgroups and a favorable safety and tolerability profile,” the company says.

Cytokinetics says aficamten was designed to “reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM.” In preclinical models, the drug was shown to reduce myocardial contractility by binding directly to cardiac myosin to prevent it from entering a force producing state, it says.