The FDA has approved a sweeping label update for Bristol Myers Squibb’s Camzyos (mavacamten), the first‑and‑only FDA‑approved cardiac myosin inhibitor for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Until Camzyos reached the market in 2022, physicians mainly relied on beta‑blockers, calcium‑channel blockers, disopyramide or invasive septal‑reduction surgery to relieve outflow obstruction. The latest update lets cardiologists cut routine echocardiograms for eligible, stable patients from once every 12 weeks to every six months and removes outright bans on moderate CYP2C19 or strong CYP3A4 inhibitors. The changes are backed by 3.5 years of data and real‑world experience in more than 15,000 U.S. patients.
The twice‑yearly echo schedule applies only after patients complete the 12‑week titration period and show a left‑ventricular ejection fraction (LVEF) ≥ 55% plus a Valsalva left‑ventricular‑outflow‑tract (LVOT) gradient < 30 mmHg (or LVOT ≥ 30 mmHg without up‑titration). Former contraindications with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors are now classed as manageable interactions that require dose adjustment and closer monitoring, while moderate to strong CYP2C19 or moderate to strong CYP3A4 inducers remain contraindicated. FDA’s decision reflects increasing confidence in the therapy’s safety profile, documented through the mandatory Camzyos Risk Evaluation and Mitigation Strategy (REMS) program.
“Simplifying treatment by reducing the frequency of echo monitoring not only improves the patient experience, but will also save time for cardiologists, allowing them to treat more patients,” said Al Reba, senior vice‑president of cardiovascular & immunology commercialization at Bristol Myers Squibb, in the company’s announcement.
Camzyos still carries a boxed warning for heart‑failure risk and is available only through the CAMZYOS REMS program. Physicians must certify, and patients must enroll and comply with ongoing LVEF monitoring requirements.
The drug’s clinical relevance continues to grow: Camzyos is recommended for persistent‑symptom oHCM in the 2023 ESC guidelines and the 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR guidance, cementing its role as a disease‑modifying option whose use is now simpler for both patients and clinics.
Camzyos has moved swiftly from a niche launch to a growth engine. Global net sales climbed from $24 million in 2022 (its first partial year on the market) to $231 million in 2023, and then jumped a further 160 % to $602 million in 2024 as uptake accelerated in both the U.S. and key ex‑U.S. markets.
Filed Under: Cardiovascular
