Bristol Myers Squibb Shares Research Supporting Correlation Between New York Heart Association Functional Class (NYHA class) and Mortality in Obstructive Hypertrophic Cardiomyopathy

Rhea-AI Summary

Bristol Myers Squibb (NYSE: BMY) presented findings at the Heart Failure Society of America Annual Scientific Meeting, indicating that increased mortality risk correlates with worsening New York Heart Association (NYHA) functional class among patients with obstructive hypertrophic cardiomyopathy (HCM). The study, involving 2,495 patients, showed varying mortality rates: 5% for NYHA class I, 9% for class II, and 13% for class III/IV over a median follow-up of 3.9 years. These results underscore the importance of assessing NYHA class in treatment outcomes.

Positive

• Study indicates mortality risk increases with worsening NYHA class, highlighting the importance of assessing functional class in therapy outcomes.
• Study based on a large, multi-centered cohort of 2,495 obstructive HCM patients provides strong real-world evidence.

Negative

• Potential risks associated with the research include the uncertainty around regulatory approvals and commercial success for related therapies.

Data presented at Heart Failure Society of America Annual Scientific Meeting show worse NYHA class correlates with increased mortality risk among patients with obstructive hypertrophic cardiomyopathy (obstructive HCM)

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced findings from a global real-world evidence study that the risk of mortality increases with worse New York Heart Association functional class (NYHA class) for patients with obstructive hypertrophic cardiomyopathy (obstructive HCM). While other studies have documented this association in HCM, this study represents one of the largest, multi-centered studies that specifically focuses on the obstructive HCM patient population.

“These data demonstrate the importance of assessing NYHA functional class in obstructive HCM patients,” said Neal Lakdawala, MD, cardiovascular medicine specialist at Brigham and Women's Hospital and lead author on the study. “We should determine the impact of therapies for obstructive HCM on patients' overall prognosis.”

Over a median follow-up of 3.9 years, the data show a 5% mortality rate in obstructive HCM patients initially classified as NYHA class I, 9% in class II, and 13% in class III/IV. Risks of all-cause mortality and the composite outcome of death or heart transplant increased with worse NYHA class at baseline (p<0.001). The study was conducted in partnership with the Sarcomeric Human Cardiomyopathy Registry (SHaRe) and presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting taking place from September 10 to 13, 2021.

The full data presentation will be available starting September 10, 2021, 6:15 p.m. - 7:15 p.m. MT on the HFSA website for registered attendees.

“As approximately half a million people are affected by obstructive HCM worldwide, these data on the association between mortality and NYHA class in obstructive HCM patients are critical globally,” said Mitch Higashi, vice president of U.S. Health Economics and Outcomes Research, Bristol Myers Squibb. “The insight provided by these real-world data in identifying at-risk patients supports improved patient outcomes as well as healthcare efficiencies overall.”

About the Study

The study analyzed 2,495 obstructive HCM patients with a mean age of 47.6 years at diagnosis, 42% of whom were female. Patient characteristics varied across NYHA class. The Sarcomeric Human Cardiomyopathy Registry (SHaRe) enrolled patients from 10 HCM specialty centers worldwide. The study used data through March 2019, analyzing patients ≥18 years old with obstructive HCM (left ventricular outflow tract (LVOT) peak gradient >30 mmHg or septal reduction therapy) and documentation of NYHA class. Patients were followed from the date of index NYHA class assessment (first documentation of NYHA class I, II, III or IV) to last SHaRe visit or death. The risks of all-cause mortality and a composite endpoint of death and heart transplant were compared across index NYHA classes using log-rank tests.

About Obstructive Hypertrophic Cardiomyopathy

Obstructive hypertrophic cardiomyopathy (obstructive HCM), the most common type of HCM, is a chronic, progressive disease in which the heart muscle becomes abnormally enlarged or thick causing the left ventricular outflow tract (LVOT) where blood leaves the heart to become obstructed by the enlarged heart muscle. As a result, obstructive HCM can lead to debilitating symptoms for patients and has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death.

The most frequent cause of obstructive HCM is mutations in the heart muscle proteins of the sarcomere and as many as 50% of patients have a hereditary predisposition to the disease. Obstructive HCM is estimated to affect 400,000-600,000 people worldwide, however many patients remain undiagnosed and/or asymptomatic.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that mavacamten may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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FAQ

What did Bristol Myers Squibb present at the Heart Failure Society Annual Meeting regarding obstructive HCM?

Bristol Myers Squibb presented findings showing that higher NYHA class correlates with increased mortality risk in obstructive hypertrophic cardiomyopathy patients.

What were the mortality rates associated with different NYHA classes in the obstructive HCM study?

The study found a 5% mortality rate for NYHA class I, 9% for class II, and 13% for classes III/IV among obstructive HCM patients.

How many patients were involved in the Bristol Myers Squibb obstructive HCM study?

The study analyzed data from 2,495 obstructive HCM patients over a median follow-up of 3.9 years.

What is the significance of the findings from the Bristol Myers Squibb study presented at the HFSA meeting?

The findings emphasize the critical need to assess NYHA functional class for better prognosis and treatment planning in obstructive HCM patients.