Ross Hadley • April 18, 2025
US FDA Updates Camzyos Label for oHCM

U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications for Obstructive HCM

Label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindications

Updated U.S. label is supported by data including long-term clinical and real-world evidence which reinforce the strong safety profile of CAMZYOS.


“In addition to the established efficacy of CAMZYOS, these meaningful updates to the label reinforce the strong safety profile of the therapy. With robust clinical and real-world data and more than 15,000 patients prescribed CAMZYOS in the U.S.,2 this medicine has redefined the treatment landscape for symptomatic obstructive HCM and can have a significant impact for patients living with the condition,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization at Bristol Myers Squibb. “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.”

The approved label update is supported by long-term clinical and real-world data, including analyses of results from the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program, real-world experience from three single-center studies, and ongoing clinical data reinforcing the safety profile of CAMZYOS through 3.5 years.

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HCMA Blog

Lisa's Letter - July Newsletter

By Lisa Salberg • July 3, 2025
Summer, greetings to all our big-hearted friends As July approaches, our focus is already on the fall and preparing for some major events, including our annual meeting coming up in October. July will also find us on the west coast in Seattle conducting a regional patient education meeting as part of our big-hearted warrior tour. We have been following the generic drug quality issue in the United States very closely and encourage you to watch the series starting with our Hill briefing in April and following with the additional webinars with our partners at Medshadow and the People's Pharmacy, and of course the ProPublica series of articles. See them all here . We are happy to have a new team member on board - we welcome Pam as our coordinator of both our All Hearts Collaborative and Hearts and Minds project. Over the next few months, you're going to be learning more about these two amazing initiatives and how we are working to provide better services for big hearts regardless of where you live, so we are meeting all of our big-hearted friends where they are. Please stay tuned for updates from these projects coming soon. We are also creating new volunteer opportunities and engagements that we hope will make it easier for you to participate in spreading the message of the importance of diagnosis, the importance of community readiness related to CPR and AED use and, of course, helping patients get to their ultimate diagnosis and getting them on the proper treatment pathways. This July I would like to recognize all of the special birthdays in my family, including HCMA Center of Excellence coordinator, Stacey Titus-brown and my daughter Rebecca Salberg. It's a milestone birthday for Becca - it’s hard to believe I have a 30-year-old child. Wishing you all a happy and healthy summer. Go build some memories!
An official seal in black & red with white letters that say HCMS Recognized Centers of Excellence

July's Topic is COE Care at the HCMA

By Sabrina Cuddy • July 3, 2025
Getting HCM care at a HCMA Recognized Center of Excellence has a positive impact on patient's outcomes. Find out why in the post by Health Educator Sabrina Cuddy

Pro Publica Releases Results of FDA Investigation

By Erica Friedman • June 26, 2025
Investigative journalists Debbie Cenziper, Megan Rose, Brandon Roberts and Irena Hwang from Pro Publica and NPR have concluded a 14-month long investigation into the quality of generic drugs coming into the United States from overseas. Among the many voices that spoke up for American patients was HCMA Founder and CEO, Lisa Salberg who has felt the effects of low-quality drugs personally. Salberg believes that fixing this problem is something we can do, even in this time, when even health care is highly politicized. Read the key takeaways from ProPublica’s 14-month investigation into the FDA’s oversight of foreign drugmakers in Threat in Your Medicine Cabinet: The FDA’s Gamble on America’s Drugs .
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