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3 clusters · 4 sources · 27 days · First seen · Last updated

Aficamten development for hypertrophic cardiomyopathy

Overview

The cardiac myosin inhibitor aficamten (brand name Myqorzo) is expanding its clinical application and regulatory reach for hypertrophic cardiomyopathy (HCM).

In England, the Medicines and Healthcare products Regulatory Agency and the National Institute for Health and Care Excellence have authorized the drug for approximately 6,600 people with obstructive HCM. NICE guidance requires implementation within 90 days, with NHS England expected to make the treatment available within 30 days of final guidance. Clinical trials indicated the drug reduces symptoms like chest pain and breathlessness while improving exercise capacity.

Concurrently, clinical data presented at the European Society of Cardiology Congress shows aficamten also significantly improves symptoms and exercise capacity in patients with the non-obstructive form of the condition (nHCM). A Phase 3 trial published in the New England Journal of Medicine involving 517 patients met its primary endpoints, demonstrating improvements in peak oxygen uptake and clinical summary scores compared to a placebo. Following these results, Cytokinetics plans to submit a supplemental U.S. marketing application for nHCM in the fourth quarter of 2026.

Other therapeutic developments for HCM include Phase 2 data for EDG-7500, an experimental oral medication from Edgewise Therapeutics. This selective cardiac sarcomere modulator is designed to target both obstructive and nonobstructive forms of the disease by aiming to slow early contraction velocity and improve relaxation without compromising overall heart pumping function.

Entities

European Society of Cardiology · Cytokinetics · Barclays · NHS England · National Institute for Health and Care Excellence (NICE)

Timeline

  1. 12 days ago

    [HEALTH] 2 sources
    New therapies show promise for treating hypertrophic cardiomyopathy

    Clinical trials show promise for new treatments for hypertrophic cardiomyopathy, with aficamten improving exercise capacity in nonobstructive cases and EDG-7500 targeting both forms of the disease.

  2. 15 days ago

    [HEALTH] 2 sources
    Cytokinetics reports positive late-stage data for heart disease drug aficamten

    Cytokinetics reported that its drug aficamten significantly improves symptoms in patients with non-obstructive hypertrophic cardiomyopathy, supporting a planned U.S. marketing application for 2026.

  3. about 1 month ago

    [HEALTH] 2 sources
    England's NHS to Offer New Aficamten Pill for Obstructive HCM

    NICE and the MHRA have approved aficamten (Myqorzo), a daily pill for obstructive hypertrophic cardiomyopathy, enabling NHS England to treat about 6,600 patients within weeks, with a confidential discount.

Sources

iatronet.gr · medicaldaily.com · medicaldialogues.in · srnnews.com

This summary has been updated 1 time: see revision history