Cytokinetics Announces MYQORZO™ (aficamten) Now Available in the U.S. for the Treatment of Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy to Improve Functional Capacity and Symptoms

Core Insights - MYQORZO™ (aficamten) has been approved by the U.S. FDA for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM), aimed at improving functional capacity and symptoms [1][4][5] - The drug is available in multiple dosages (5 mg, 10 mg, 15 mg, and 20 mg) and is a once-daily oral allosteric and reversible inhibitor of cardiac myosin motor activity, which reduces cardiac contractility and left ventricular outflow tract (LVOT) obstruction in patients with oHCM [2][17] Company Overview - Cytokinetics is a specialty cardiovascular biopharmaceutical company with over 25 years of experience in muscle biology, focusing on developing new medicines for cardiac muscle dysfunction [21] - The launch of MYQORZO marks a significant milestone for Cytokinetics, reflecting its commitment to patients and the culmination of extensive scientific and clinical development efforts [3][21] Product Details - MYQORZO is indicated specifically for adults with symptomatic oHCM, and it works by inhibiting cardiac myosin to alleviate symptoms associated with the condition [5][17] - The drug has been engineered for predictable exposure response, rapid onset of action, and reversibility, making it a novel treatment option for patients [17] Clinical and Safety Information - The approval of MYQORZO was based on positive results from the pivotal Phase 3 clinical trial, SEQUOIA-HCM, published in the New England Journal of Medicine [4] - Important safety information includes a boxed warning for the risk of heart failure due to reduced left ventricular ejection fraction (LVEF), necessitating regular echocardiogram assessments during treatment [6][9][10] Distribution and Support Programs - MYQORZO is available through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the MYQORZO REMS Program, which includes specific requirements for prescribers, patients, and pharmacies [11][15] - Cytokinetics has established a personalized support program, MYQORZO & You™, to assist patients in navigating their treatment journey and provide education and financial assistance [4][21]