MYQORZO

Aficamten exposure increases dose proportionally following single doses of 1 mg to 75 mg and multiple once daily doses of 5 mg to 20 mg. Aficamten pharmacokinetics was comparable between healthy subjects and patients with oHCM. Geometric mean accumulation ratios for aficamten were similar across dose levels and ranged from 4.6 to 4.8. Steady state is predicted to be reached following approximately 17 days of once daily dosing of MYQORZO in patients with oHCM.

AbsorptionAficamten is rapidly abso...

The efficacy of MYQORZO was evaluated in SEQUOIA-HCM (NCT05186818), a phase 3, multicenter, randomized, double-blind, placebo-controlled study in 282 adults (142 aficamten, 140 placebo) with symptomatic New York Heart Association (NYHA) class II and III oHCM, LVEF ≥60%, and resting and post-Valsalva peak LVOT-G ≥30 and ≥50 mmHg at screening, respectively. Patients who completed SEQUOIA-HCM were eligible to participate in an ongoing, open-label, single-arm extension study (FOREST-HCM). Patients with a known infiltrative or storage disorder causing cardiac hypertrophy such as Noonan syndrome, Fa...

The following adverse reaction is discussed in other sections of labeling: Heart Failure [see Warnings and Precautions (5.1) ] The most common adverse reaction was hypertension (8%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cytokinetics at 1-833-633-2986 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be dire...

MYQORZO is contraindicated with concomitant use of rifampin [see Warnings and Precautions (5.3) and Drug Interactions (7.1) ] . Rifampin ( 4 )

Risk of Heart Failure : Consider decreasing dose or dose interruption in patients with serious intercurrent illness. ( 2.2 , 5.1 ) Drug Interactions Leading to Increased Risk of Heart Failure or Loss of Effectiveness: Advise patients of the potential for drug interactions. ( 2.3 , 5.3 , 17 ) 5.1 Heart Failure MYQORZO reduces cardiac contractility, which can reduce LVEF and cause heart failure. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., n...

7 DRUG INTERACTIONS Drugs that inhibit multiple pathways of MYQORZO elimination, strong CYP2C9 inhibitors, or moderate-to-strong CYP3A inducers may increase risk of heart failure. MYQORZO dose reduction and additional monitoring may be required when initiating or discontinuing these drugs. ( 2.3 , 7.1 ) 7.1. Potential for Other Drugs to Affect Plasma Concentrations of MYQORZO Aficamten is primaril...