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Camzyos (MYK-461)
Camzyos works by inhibiting the Myosin-7 protein, which is involved in the thickening of heart muscle cells.
At a glance
| Generic name | MYK-461 |
|---|---|
| Sponsor | Myokardia Inc |
| Drug class | Cardiac Myosin Inhibitor [EPC] |
| Target | Myosin-7 |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Think of your heart muscle cells like a bunch of rubber bands. In people with HCM, these rubber bands get too thick and start to get in the way of blood flowing out of the heart. Camzyos helps by stopping the rubber bands from getting thicker, making it easier for blood to flow.
Approved indications
- Obstructive hypertrophic cardiomyopathy (HCM)
Boxed warnings
- WARNING: RISK OF HEART FAILURE CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction [see Warnings and Precautions (5.1) ] . Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status [see Dosage and Administration (2.1) and Warnings and Precautions (5.1) ] . Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following [see Contraindications (4) and Warnings and Precautions (5.2) ] : • Strong CYP2C19 inhibitors • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called CAMZYOS REMS PROGRAM [see Warnings and Precautions (5.3) ]. WARNING: RISK OF HEART FAILURE See full prescribing information for complete boxed warning. • CAMZYOS can cause heart failure due to systolic dysfunction. ( 5.1 ) • Echocardiogram assessments of left ventricular ejection fraction (LVEF) required before and during CAMZYOS use. ( 2.1 ) • Initiation in patients with LVEF <55% not recommended. Interrupt if LVEF <50% or if worsening clinical status. ( 2.1 , 5.1 ) • Certain CYP450 inhibitors and inducers are contraindicated in patients taking CAMZYOS because of an increased risk of heart failure. ( 4 , 5.2 , 7 ) • CAMZYOS is available only through a restricted program called the CAMZYOS REMS Program. ( 5.3 )
Common side effects
- Atrial fibrillation
- Cardiac failure
- Echocardiogram abnormal
- Ejection fraction decreased
Drug interactions
- Strong CYP2C19 Inhibitors
- Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers
- Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors
- Negative Inotropes
Key clinical trials
- A Study to Assess the Real-World Effectiveness of Mavacamten in Adult Patients With Obstructive Hypertrophic Cardiomyopathy in China
- A Study of Mavacamten in Adults With Obstructive Hypertrophic Cardiomyopathy in India (ROVER) (PHASE4)
- A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed MAVERICK-HCM or EXPLORER-HCM (PHASE2,PHASE3)
- Mavacamten Post-marketing Surveillance in Patients With Obstructive Hypertrophic Cardiomyopathy in Japan
- A Study of Mavacamten in Obstructive Hypertrophic Cardiomyopathy (PHASE3)
- The Therapeutic Value of Mavacamten in Hypertrophic Cardiomyopathy With Mid-to-Apical Left Ventricular Obstruction (PHASE4)
- A Study to Evaluate Mavacamten in Adolescents With Symptomatic Obstructive Hypertrophic Cardiomyopathy (PHASE3)
- Real-World Effectiveness of Mavacamten in Canada
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Camzyos CI brief — competitive landscape report
- Camzyos updates RSS · CI watch RSS
- Myokardia Inc portfolio CI