RegulatoryJul 30, 2026, 06:22 AM
Cytokinetics' MYQORZO® Gets UK Marketing Authorization & NICE Nod
AI Summary
Cytokinetics announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted MYQORZO® (aficamten) marketing authorization across the United Kingdom. Concurrently, the National Institute for Health and Care Excellence (NICE) recommended aficamten for use in eligible adult patients in England and Wales. The drug is indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) and is expected to be available through the NHS later this year.
Key Highlights
- MHRA granted marketing authorization for MYQORZO® (aficamten) across the United Kingdom.
- NICE issued guidance recommending aficamten for eligible adult patients in England and Wales.
- Aficamten treats symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult patients.
- It can be used as an add-on to standard care or alone if other treatments are contraindicated.
- Phase 3 SEQUOIA-HCM study showed a 1.7 mL/kg/min improvement in peak oxygen uptake.
- Most common adverse reactions included hypertension (7.7%) and palpitations (7.0%).
- Availability through the NHS is expected later this year.
Price Impact
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