Cytokinetics' cardiomyopathy drug cleared for NHS use

Cytokinetics is one of the first drugmakers to benefit from the UK's dual regulatory and reimbursement appraisals, getting a green light for its obstructive hypertrophic cardiomyopathy (HCM) drug Myqorzo.

The simultaneous reviews by the MHRA medicines regulator and reimbursement authority NICE have cleared the way for cardiac myosin inhibitor Myqorzo (aficamten) to be used by the NHS as an add-on to standard treatment for adults with NYHA class II-III obstructive HCM, a disease that is characterised by thickening of cardiac muscle and stiffness in the left ventricle and interferes with the function of the heart.

Their decisions make Myqorzo the first rival to Bristol Myers Squibb's first-to-market cardiac myosin inhibitor Camzyos (mavacamten), which has been cleared for NHS use by NICE in a similar indication since 2023.

Both drugs can be used on top of standard care, including beta-blockers, non-dihydropyridine calcium-channel blockers, or disopyramide, or alone if these treatments are contraindicated.

Around 1 in 500 people in the UK has HCM, and in roughly half of cases it is inherited, according to NICE. The health technology assessment (HTA) agency said Cytokinetics had to demonstrate that the costs associated with Myqorzo were similar or lower than Camzyos to get a positive recommendation.

"It is likely to be as effective as mavacamten, the other NICE-approved treatment for HCM, and patients may need fewer monitoring scans to find the right dose," it added.

"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," commented Joseph Dagher, Cytokinetics' European head.

The US drugmaker won its first approval for Myqorzo in the US last December, following that with approvals in the EU and China and a first European launch for the drug, in Germany, in June. It made around $5 million in sales from Myqorzo in the first quarter of this year from initial US sales, while BMS recorded $314 million for Camzyos, up 97%, in the same period.

Cytokinetics is predicting blockbuster sales for its product once its rollout gathers pace, and could be helped in that endeavour by recently reported data in non-obstructive HCM, a milder form of the disease in which there is no obstruction in blood flow from the heart to the body.

Camzyos failed a phase 3 trial in that setting, leading to some speculation that obstructive and non-obstructive HCM could be two distinct diseases. However, Myqorzo undermined that view by showing efficacy in the ACACIA-HCM, which puts it in the lead to bring a drug for non-obstructive HCM to market.