FDA Updates Prescribing Information for Bristol Myers Squibb’s Camzyos to Reduce Echocardiography Monitoring Requirements
The simplified requirements for Camzyos are expected to ease prior contraindications, thereby simplifying treatment and expanding eligibility in patients with symptomatic New York Heart Association Class II-III obstructive hypertrophic cardiomyopathy.
Image Credit: Adobe Stock Images/kokoson6
The FDA has updated the US prescribing information for Bristol Myers Squibb’s (BMS) Camzyos (mavacamten; 2.5 mg, 5 mg, 10 mg, 15 mg capsules) in an effort to reduce echocardiography monitoring requirements and ease previous contraindications. As a result, more patients with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) will now be eligible for treatment, according to BMS. The updated label was approved based on robust clinical and real-world data, including ongoing findings from the Camzyos risk evaluation and mitigation strategy (REMS) program and safety results extending over 3.5 years.1
“In addition to the established efficacy of Camzyos, these meaningful updates to the label reinforce the strong safety profile of the therapy,” said Al Reba, SVP, cardiovascular & immunology commercialization, BMS, in a press release.
With the new guidance, echocardiography monitoring is now required every six months instead of every 12 weeks for patients in the maintenance phase who have a left ventricular ejection fraction (LVEF) ≥55% and a Valsalva left ventricular outflow tract (LVOT) gradient <30 mmHg. The treatment is also no longer contraindicated with moderate CYP2C19 inhibitors or strong CYP3A4 inhibitors, which have been reclassified as drug interactions. This change provides physicians with greater flexibility in prescribing Camzyos to a broader group of patients, according to BMS.
Despite these updates, the therapy continues to carry a boxed warning for the risk of heart failure due to systolic dysfunction and remains available only through the Camzyos REMS program. BMS advises against initiating treatment in patients with LVEF <55%.
Patients who experience a drop in LVEF below 50% or show signs of heart failure or clinical deterioration should discontinue treatment immediately. Using Camzyos alongside certain cytochrome P450 inhibitors or discontinuing certain inducers can raise the risk of heart failure due to systolic dysfunction. As such, Camzyos should not be used with strong CYP2C19 inhibitors or with moderate to strong inducers of CYP2C19 or CYP3A4.1
According to MedPage Today, approximately one in every 500 adults is currently living with a form of cardiomyopathy. Among heart conditions, it remains a leading cause of death in the United States.2 A study published by the American Heart Association estimates that hypertrophic cardiomyopathy (HCM) has a prevalence between 0.16% and 0.29% in the adult population, with rates expected to be higher in older individuals due to age-dependent disease expression.3
Data from the Centers for Disease Control and Prevention show that heart disease led to 702,880 deaths in 2022. From 2019 to 2020, the economic burden of heart disease totaled $252.2 billion, including healthcare costs, medications, and lost productivity. In 2021, Black individuals represented 22.6% of all heart disease-related deaths, which is higher than any other racial or ethnic group. Asian Americans accounted for 18.6%, White individuals 18%, and Hispanic populations 11.9%.4
“With robust clinical and real-world data and more than 15,000 patients prescribed Camzyos in the United States, this medicine has redefined the treatment landscape for symptomatic obstructive HCM and can have a significant impact for patients living with the condition,” continued Reha, in the press release. “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.”
References
1. U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications. BMS. April 17, 2025. Accessed April 21, 2025. https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Updates-CAMZYOS-mavacamten-Label-to-Reduce-Echocardiography-Monitoring-Requirements-and-Contraindications/default.aspx
2. Cardiomyopathy: Epidemiology, Etiology, and Pathophysiology. Medpage Today. Accessed April 21, 2025. https://www.medpagetoday.com/medical-journeys/cardiomyopathy/97961
3. Heart Disease Facts. CDC. Accessed April 21, 2025. https://www.cdc.gov/heart-disease/data-research/facts-stats/index.html
4. Hypertrophic Cardiomyopathy: Genetics, Pathogenesis, Clinical Manifestations, Diagnosis, and Therapy. AHAIASA Journals. Accessed April 21, 2025. https://www.ahajournals.org/doi/10.1161/circresaha.117.311059
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