Cytokinetics wins UK approval and NICE backing for heart drug

Cytokinetics won UK marketing authorisation for MYQORZO and positive guidance from the National Institute for Health and Care Excellence on July 30, clearing the way for aficamten to move toward NHS use in England and Wales. The double decision matters because U.K. approval alone does not guarantee access: NICE guidance is often the gatekeeper for whether the National Health Service pays for a medicine and how widely it is used.

NICE said aficamten could be used as an option for adults with symptomatic obstructive hypertrophic cardiomyopathy who are in New York Heart Association class 2 to 3. The guidance also limited use to patients already on a stable beta-blocker or verapamil when their condition has not been adequately controlled, or to people for whom beta-blockers and calcium-channel blockers are not suitable or are not tolerated. NICE’s recommendation was tied to a simple discount patient access scheme, showing that pricing negotiations were part of the pathway to public reimbursement.

The scale of the decision is not trivial. NICE said around 6,600 people in England could benefit from aficamten, a once-daily pill marketed as MYQORZO. The U.K. government separately said thousands of patients could benefit from the new treatment for a serious heart condition, underscoring the public-health significance of a medicine aimed at a disease where treatment options remain limited.

Aficamten is an oral cardiac myosin inhibitor designed to reduce the hypercontractility associated with hypertrophic cardiomyopathy. The drug had already cleared the U.S. Food and Drug Administration in 2025, where the label carries a boxed warning that it can cause heart failure due to systolic dysfunction and requires echocardiogram checks of left ventricular ejection fraction before and during use. That safety framework now sits alongside a new U.K. access pathway, showing how regulators and payers assess both benefit and risk before a cardiac drug reaches routine care.

For Cytokinetics, the U.K. ruling marked a major commercial step after earlier progress in the United States, Europe and China. For the NHS, it was another test of where the system draws the line on cost-effectiveness for a new class of heart medicines, and whether fast-track innovation can translate into funded treatment for patients rather than approval on paper alone.