Cytokinetics (NASDAQ: CYTK) announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorisation in the United Kingdom for MYQORZO (aficamten), a treatment for symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in eligible adult patients with a New York Heart Association (NYHA) class of II to III.

At the same time, the National Institute for Health and Care Excellence (NICE) issued guidance recommending aficamten for use in eligible adult patients in England and Wales. According to NICE, aficamten may be used as an add-on to individually optimised standard care, including beta-blockers, non-dihydropyridine calcium-channel blockers, or disopyramide, or alone if those treatments are contraindicated, subject to a commercial arrangement with the company.

The MHRA authorisation was based on data from SEQUOIA-HCM, a phase 3 double-blind, placebo-controlled randomised study involving 282 adults treated for 24 weeks. The primary endpoint was change from baseline to week 24 in peak oxygen uptake. Aficamten produced a mean change of 1.8 mL/kg/min compared with 0.0 mL/kg/min for placebo, with a least squares mean difference of 1.7 mL/kg/min and a confidence interval of 1.0 to 2.4 (p < 0.001).

The most commonly reported adverse reactions included hypertension (7.7%), palpitations (7.0%), dizziness (4.2%), and systolic dysfunction (3.5%).

Joseph Dagher, Senior Vice President and Head of Europe at Cytokinetics, said the company is "committed to supporting access for eligible adult patients through the NHS upon availability expected later this year."

Aficamten is a cardiac myosin inhibitor. HCM affects approximately one in 500 Europeans, according to European Society of Cardiology guidelines, with roughly half of those patients having the obstructive form of the disease.