Cytokinetics says UK MHRA approves MYQORZO for obstructive hypertrophic cardiomyopathy
CYTK•UK approval and NICE guidance for MYQORZO
Cytokinetics said the UK Medicines and Healthcare products Regulatory Agency, or MHRA, has granted marketing authorization for MYQORZO (aficamten) to treat symptomatic obstructive hypertrophic cardiomyopathy in eligible adults.
NICE also issued positive guidance recommending aficamten for eligible adult patients in England and Wales, supporting NHS use under a commercial arrangement.
Clinical data supporting the authorization
The authorization was backed by Phase 3 SEQUOIA-HCM data showing a 1.7 mL/kg/min improvement in peak oxygen uptake versus placebo at 24 weeks.
