FDA: Bristol CAMZYOS Label to Reduce ECG Monitoring Requirements, Contraindications

Bristol Myers Squibb (NYSE: BMY) announced that the FDA has updated the U.S. Prescribing Information for CAMZYOS®, their cardiac myosin inhibitor for treating obstructive hypertrophic cardiomyopathy (oHCM). The key updates include:

Reduced echo monitoring frequency from every 12 weeks to every 6 months for eligible maintenance phase patients
Removal of contraindications for moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors
Expanded patient eligibility with revised dosing and monitoring guidelines



These updates are supported by long-term clinical and real-world data from over 15,000 U.S. patients, including REMS Program analyses and three single-center studies showing safety through 3.5 years. CAMZYOS remains subject to a Boxed WARNING for heart failure risk and is only available through a restricted REMS program.

https://www.stocktitan.net/news/BMY/u-s-food-and-drug-administration-updates-camzyos-mavacamten-label-to-7im5gwkpjxw0.html