Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication CAMZYOS ® 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. CAMZYOS is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional… FDA label
Also known as MYK-461, BMS-986327, Mavacamten capsule
Mavacamten · 2 trials · 2 indications
To compare the effect of a 30-week course of mavacamten with placebo on Valsalva LVOT peak gradient as determined by Doppler echocardiography
Determination of pharmacokinetics parameters as measured by area under curve AUC(0-last), AUC(0-inf)
Determination of pharmacokinetics parameters as measured by maximum concentration (Cmax)
Determination of pharmacokinetics parameters as measured by time to maximum concentration (Tmax)
Determination of pharmacokinetics parameters as measured by elimination half-life (T1⁄2)
Determination of pharmacokinetics parameters as measured by apparent volume of distribution (Vd/F)
Determination of pharmacokinetics parameters as measured by apparent clearance (CL/F)
| Arm | Type | Description |
|---|---|---|
| Mavacamten | EXPERIMENTAL | Mavacamten Capsules |
| placebo | PLACEBO_COMPARATOR | Matching Placebo Capsules |
| Cohort 1: Mavacamten 15 mg | EXPERIMENTAL | Cohort 1: 15 mg capsules × 1 on Day 1 |
| Cohort 2: Mavacamten 25 mg | EXPERIMENTAL | Cohort 2: 10 mg capsules x 1 and 15 mg capsules x 1 on Day 1 |
| Cohort 3: Mavacamten 15 mg | EXPERIMENTAL | Cohort 3: 15 mg capsules × 1 on Day 1 |
| Cohort 4: Mavacamten 15 mg | EXPERIMENTAL | Cohort 4: 15 mg capsules × 1 on Day 1 |
| Name | Type | Description |
|---|---|---|
| Mavacamten | DRUG | Mavacamten Capsules |
| Placebo | DRUG | Matching PBO capsules during placebo controlled period，and mavacamten capsules during long term extension period |
Inclusion Criteria: * Is at least 18 years old at screening. * Body weight is greater than 45 kg at screening. * Has adequate acoustic windows to enable accurate TTEs * Diagnosed with oHCM * Has documented LVEF ≥ 55% at rest. * Has a valid measurement of Valsalva LVOT peak gradient at screening * H...