Drug updated on 9/4/2024
Dosage Form | Capsule (oral; 2.5 mg, 5 mg, 10 mg, 15 mg) |
Drug Class | Cardiac myosin inhibitors |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.
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Summary
- Camzyos (mavacamten) is indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. No changes needed.
- This summary is based on the review of five systematic review(s)/meta-analysis(es). [1-5]
- Mavacamten demonstrated a higher rate of achieving the primary composite endpoint compared to placebo (RR = 1.92, 95% CI [1.28, 2.88]; P = 0.002).
- Significant improvement in ≥1 NYHA class was observed with mavacamten (RR = 2.10, 95% CI [1.66, 2.67]; P < 0.00001), with three studies showing improvements ranging from 34% to 80%.
- Mavacamten significantly improved KCCQ clinical summary scores (MD = 8.08, 95% CI [4.80, 11.37]; P < 0.00001), though one study reported no significant effect in the overall population (SMD = 0.43, P = 0.08) but showed significant improvement in the HOCM subgroup (SMD = 0.65, 95% CI [0.44-0.87]).
- There was a small increase in adverse events with mavacamten, but this was not statistically significant. However, higher rates of treatment-emergent adverse events (TEAE) were observed compared to placebo.
- No statistically significant difference in serious adverse events (SAE) between mavacamten and placebo was observed across multiple studies. Common specific adverse events included atrial fibrillation and decreased left ventricular ejection fraction, with recovery noted without long-term sequelae.
- The studies primarily included adult patients (≥18 years) with a mean age of 56 years, encompassing Caucasian and Chinese ethnicities with both obstructive (oHCM) and non-obstructive (nHCM) hypertrophic cardiomyopathy (HCM), with significant focus on the hypertrophic obstructive cardiomyopathy (HOCM) subgroup, which demonstrated clinically relevant improvements in KCCQ and pVO2 and a significant decrease in ejection fraction.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Camzyos (mavacamten) Prescribing Information. | 2022 | Bristol Myers Squibb Brisbane, CA |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
A systematic review and meta-analysis of the efficacy and safety of Mavacamten therapy in international cohort of 524 patients with hypertrophic cardiomyopathy. | 2024 | Heart failure reviews |
Efficacy and safety of mavacamten in treatment of hypertrophic cardiomyopathy: A systematic review and meta-analysis. | 2023 | Future Science OA |
Efficacy and safety of mavacamten in the treatment of hypertrophic cardiomyopathy: A systematic review. | 2023 | Heart, Lung & Circulation |
Safety and efficacy of mavacamten for treatment of hypertrophic cardiomyopathy: A systematic review and meta-analysis of randomized clinical trials. | 2023 | The Egyptian Heart Journal |
Mavacamten treatment for hypertrophic cardiomyopathy: A systematic review and meta-analysis of randomized controlled trials. | 2023 | Current Problems in Cardiology |