MYQORZO® Drug Approval
Cytokinetics' MYQORZO® Gains UK Marketing Approval and Positive NICE Guidance for oHCM Treatment
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Cytokinetics has won approval to sell MYQORZO® (aficamten) across the United Kingdom, a major step for patients with a serious heart condition. The Medicines and Healthcare products Regulatory Agency (MHRA) granted the marketing authorisation, and the National Institute for Health and Care Excellence (NICE) issued positive guidance recommending the drug for eligible adults in England and Wales, according to GlobeNewswire.
Aficamten treats symptomatic obstructive hypertrophic cardiomyopathy, or oHCM — a condition where the heart muscle thickens and blocks blood flow, causing symptoms like breathlessness and chest pain. It targets patients rated NYHA class II or III, meaning those with mild to moderate limitations on daily activity.
What oHCM Is and Why This Drug Matters
Obstructive hypertrophic cardiomyopathy (oHCM) is a genetic heart disease. The heart muscle grows too thick, making it harder for the heart to pump blood properly. Patients can suffer from fatigue, dizziness, and shortness of breath even during light activity. There are limited treatment options for many people living with the condition.
Aficamten works differently from older treatments. It is a cardiac myosin inhibitor, meaning it reduces the force of the heart's muscle contractions to ease the obstruction. Cytokinetics said the drug is meant to support NHS access for all eligible adult patients, according to AP News.
MHRA Approval and NICE Recommendation Secured Simultaneously
The MHRA granted MYQORZO® a full marketing authorisation across the entire UK. At the same time, NICE — the body that decides which drugs the NHS should fund — issued guidance backing the drug for use in England and Wales. Getting both decisions at once is a significant commercial and regulatory win for Cytokinetics.
The NICE recommendation means eligible patients in England and Wales can expect NHS access. Cytokinetics said it is committed to supporting that access as quickly as possible, according to Yahoo Finance.
Side Effects Patients and Doctors Should Know About
The most common side effects reported in trials were hypertension (7.7%), palpitations (7.0%), dizziness (4.2%), and systolic dysfunction (3.5%). Systolic dysfunction means the heart muscle weakens and pumps less blood than normal — a known risk with drugs that reduce heart muscle force.
Doctors will need to monitor patients carefully, particularly for signs of reduced heart function. The drug carries a black triangle symbol (▼), meaning it is subject to extra safety monitoring in the UK. This is standard for newly approved medicines, not a sign of unusual danger.
Cytokinetics Pushes Into the UK Market With NHS Backing
The UK approval adds to Cytokinetics' growing footprint for aficamten. The company is focused on making the drug available through the NHS for eligible adults. A NICE recommendation is critical in the UK — without it, NHS trusts are far less likely to fund a new drug, no matter its regulatory status.
Cytokinetics said it sees MYQORZO® as a meaningful option for the oHCM patient population in the UK. The dual regulatory and reimbursement wins position the company to begin commercial launch without the delays that often follow a marketing authorisation alone, according to AP News.
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