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Camzyos
Published
Product name
Camzyos
Active ingredient
Mavacamten
Submission type
New chemical entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Camzyos (mavacamten) was approved for the following therapeutic use:
Camzyos is indicated for the treatment of adults with symptomatic NYHA class II-III obstructive hypertrophic cardiomyopathy.
How this medicine works
Mavacamten is a selective, allosteric, and reversible cardiac myosin inhibitor. Mavacamten modulates the number of myosin heads that can enter power-generating states, thus reducing, (or in hypertrophic cardiomyopathy (HCM) normalising), the probability of force-producing systolic and residual diastolic crossbridge formation. Mavacamten also shifts the overall myosin population towards an energy sparing, but recruitable, super-relaxed state. Excess cross-bridge formation and dysregulation of the super relaxed state of myosin are mechanistic hallmarks of HCM, which can result in hypercontractility, impaired relaxation, excess energy consumption, and myocardial wall stress. In HCM patients, myosin inhibition with mavacamten normalises contractility, reduces dynamic left ventricular outflow tract obstruction, and improves cardiac filling pressures and biomarkers of cardiac stress, improving symptoms and exercise capacity.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Camzyos was considered favourable for the therapeutic use approved.