Real-World Data on Mavacamten Builds on Clinical, Safety Profile


Bristol Myers Squibb will also present findings on apixaban (Eliquis) at the American College of Cardiology Annual Scientific Session and Expo.

Bristol Myers Squibb announced the presentation of data at the American College of Cardiology (ACC) Annual Scientific Session and Expo, held in Atlanta, Georgia from April 6 to April 8, 2024. Data included robust safety and clinical findings of mavacamten (Camzyos) as well as compliance with the Risk Evaluation and Mitigation Strategy Program.1

3d illustration of human heart and cardiogram on futuristic blue background. | Image Credit: Artem -

Image Credit: Artem -

“The therapeutic benefit of [mavacamten] in real-world practice, demonstrated by our data at ACC, builds on the well-established clinical program and further underscores the importance of this transformational medicine which is the first and only approved cardiac myosin inhibitor. With thousands of patients around the world treated to date, [mavacamten] is redefining the treatment landscape for this patient population and may offer hope to countless others moving forward,” Roland Chen, MD, senior vice president and head of Development, Immunology, Cardiovascular, & Neurology at Bristol Myers Squibb, said in the press release. “In addition to showcasing our growing body of real-world evidence and safety data for [mavacamten] at ACC, we look forward to highlighting additional data from our cardiovascular portfolio, including an analysis of the real-world clinical impact of [apixaban (Eliquis)].”1

According to the American Heart Association, cardiovascular disease accounted for approximately 931,578 deaths in the United States in 2021. Further, about 48.6% of adults in the United States had some form of cardiovascular disease between 2017 to 2020.2

In one poster session for mavacamten, the results showed that approximately 1% of the 1524 patients reported clinical heart failure that required hospitalization and 2.8% reported a decrease in left ventricular ejection fraction (LVEF) to less than 50% in 10-month post-launch data, according to the press release. The data was also consistent with the safety profile of mavacamten in clinical practice.1

Furthermore, another study showed that 96% of 53 individuals treated with mavacamten in a real-world analysis had improvements in cardiovascular symptoms and 49% had improvements in 1 or more New York Heart Association class at 24 weeks. Furthermore, the data showed that the resting and Valsalva left ventricular outflow tract (LVOT) gradient decreased during the first 4 weeks after treatment initiation and there were statistically significant reductions from baseline at 24 weeks, according to the press release. Investigators reported that no individuals required cessation of treatment due to reduction in LVEF or other adverse events. However, 2 individuals did temporarily discontinue the drug because of Valsalva LVOT gradient less than 20 mmHg during the treatment period, according to the press release.1

Key Takeaways

  1. Real-world data suggests a good safety profile with a low rate of hospitalization due to heart failure (1%) and a decrease in ejection fraction below 50% (2.8%) after 10 months of use.
  2. Another study showed improvements in cardiovascular symptoms (96%) and functional class (49%) in patients treated with mavacamten for 24 weeks.
  3. Mavacamten is the first FDA-approved cardiac myosin inhibitor, offering a new treatment option for HCM.

For apixaban, real world data were from patients with non-valvular atrial fibrillation (NVAD) and Medicare who were previously treated with warfarin and who switched to a direct oral anticoagulant (DOAC), which included apixaban, dabigatran, or rivaroxaban. The data showed that those receiving apixaban had a significantly lower risk of stroke or systemic embolism and major bleeding than individuals on dabigatran or rivaroxaban, according to the press release. The analysis shows the rates of stroke or systemic embolism and major bleeding in patients with NVAD with Medicare that was associated with switching from warfarin to different DOACs.1

  1. Bristol Myers Squibb to Present Data at the American College of Cardiology Annual Scientific Session 2024 Reinforcing Extensive Body of Evidence in Clinical and Real-World Settings Across Cardiovascular Portfolio. News release. Bristol Myers Squibb. March 25, 2024. Accessed March 27, 2024.
  2. Martin SS, Aday AW, Almarzooq ZI, et al; on behalf of the American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. 2024 Heart disease and stroke statistics: a report of US and global data from the American Heart Association. Circulation. 2024. doi:10.1161/CIR.0000000000001209
Related Videos
pharmacy oncology, Image Credit: © Konstantin Yuganov -
Mayo Clinic oncology pharmacy
A panel of 5 experts on ASCVD
A panel of 5 experts on ASCVD
A panel of 5 experts on ASCVD
A panel of 5 experts on ASCVD
Testicular cancer and prostate cancer concept. | Image Credit: kenchiro168 -
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk -
© 2024 MJH Life Sciences

All rights reserved.