Cytokinetics Receives UK Marketing Authorization For MYQORZO For Treatment Of Symptomatic Obstructive Hypertrophic Cardiomyopathy In Adult P
At the same time the National Institute for Health and Care Excellence (NICE) has issued guidance recommending aficamten for use in eligible adult patients in England and Wales. The guidance from NICE states that aficamten can be used as an option to treat symptomatic oHCM in eligible adults with a NYHA class of II to III. It can only be used as an add-on to individually optimised standard care including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, or alone if these treatments are contraindicated, and if the company provides it according to the commercial arrangement. "We are pleased to have secured a marketing authorisation for aficamten and to see positive guidance from NICE for eligible adult patients in England and Wales," said Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics. "We are grateful for the collaborations that made th...
At the same time the National Institute for Health and Care Excellence (NICE) has issued guidance recommending aficamten for use in eligible adult patients in England and Wales.
The guidance from NICE states that aficamten can be used as an option to treat symptomatic oHCM in eligible adults with a NYHA class of II to III.
It can only be used as an add-on to individually optimised standard care including beta-blockers, non-dihydropyridine calcium-channel blockers or disopyramide, or alone if these treatments are contraindicated, and if the company provides it according to the commercial arrangement. "We are pleased to have secured a marketing authorisation for aficamten and to see positive guidance from NICE for eligible adult patients in England and Wales," said Joseph Dagher, Senior Vice President and Head of Europe, Cytokinetics. "We are grateful for the collaborations that made this review possible for concurrent MHRA and NICE decisions and are committed to supporting access for eligible adult patients through the NHS upon availability expected later this year." The MHRA assessment of aficamten drew on data from SEQUOIA-HCM, a phase 3 multicentre double-blind placebo-controlled randomised study in 282 adults (142 aficamten, 140 placebo) treated for 24 weeks.1 The primary endpoint was the change from baseline to Week 24 in peak oxygen uptake (pVO2) measured by cardiopulmonary exercise testing.
Aficamten resulted in a statistically significant improvement in peak oxygen uptake compared with placebo (mean change 1.8 mL/kg/min with aficamten versus 0.0 mL/kg/min with placebo; least squares mean difference 1.7 mL/kg/min, 95% confidence interval 1.0 to 2.4; p < 0.001).1 Further information, including efficacy and safety data, is provided in the aficamten Summary of Product Characteristics.2 The most commonly reported adverse reactions with aficamten were hypertension (7.7%), palpitations (7.0%), dizziness (4.2%) and systolic dysfunction (3.5%).2