BMS – HCM Beat

FDA Approval of Mavacamten Delayed

Published on November 20, 2021November 20, 2021 by hcmbeat3 Comments

The U.S. Food and Drug Administration (FDA) has postponed the date by which it must complete its review of mavacamten – the first drug made specifically to treat HCM. The FDA was originally scheduled to announce its decision in late January 2022, but that date has now been postponed until April 28, 2022, which is the new “PDUFA date” or the date by which the FDA must respond to the new drug application.

The FDA has not asked Bristol Myers Squibb (BMS) to submit any additional data, but it wants to spend more time reviewing the proposed Risk Evaluation Mitigation Strategy or REMS which is the safety profile of the drug. The FDA can require REMS for certain drugs with safety concerns to ensure that the benefits of the medication will outweigh any risks.

BMS acquired the drug mavacamten, a first in class myosin inhibitor, through its $13.1 billion acquisition of San Francisco biotech company MyoKardia late last year.

You can read more about mavacamten and its journey in these past entries from HCMBeat:

2 Companies Testing Drugs for HCM

HCM Clinical Trials – the Latest News

HCM Drug Shows Improvement to Heart Structure

More Positive Data on Mavacamten Presented at ACC Meeting

More Positive Results for MyoKardia Drug

MyoKardia Announces Positive Results from EXPLORER Trial

MyoKardia’s EXPLORER Trial Big Success

Mavacamten Approaches Finish Line

BMS Launches New HCM Awareness Campaign Featuring Utah Jazz Player Jared Butler

Published on November 15, 2021November 20, 2021 by hcmbeatLeave a comment

Bristol Myers Squibb has launched a new hypertrophic cardiomyopathy awareness campaign and website entitled “Could it be HCM?” The campaign launch is in connection with the expected early 2022 FDA approval for the first-in-class cardiac myosin inhibitor drug mavacamten,

A video made for the campaign features professional basketball player Jared Butler of the Utah Jazz. In the video, Butler shares his surprise and dismay when he learned of his HCM diagnosis. Butler was fortunate that he was cleared to play basketball by his doctors at the Mayo Clinic who continue to follow him closely. He was even featured in People Magazine talking about his HCM. See also this article in the Salt Lake Tribune.

The website described what happens to the heart in HCM, the symptoms of HCM, and provides resources for dealing with a diagnosis of HCM.

Check it out!

HCM News from 2021 AHA Scientific Sessions

Published on November 14, 2021November 15, 2021 by hcmbeatLeave a comment

This year at the AHA Scientific Sessions several presentations focused on HCM. A couple receiving attention included:

SPIRIT-HCM, a Cleveland Clinic study which looked at the effectiveness of myectomy in improving symptoms in patients with obstructive hypertrophic cardiomyopathy. This study used patient self-reported questionnaires to measure each patient’s improvement in symptoms and quality of life following surgery. The study showed that myectomy is highly effective in reducing symptoms and in improving quality of life following surgery.
More data was presented by Bristol Myers Squibb (BMS) regarding its experimental drug mavacamten for obstructive hypertrophic cardiomyopathy. This data showed a sustained reduction in certain biomarkers of heart stress over a longer period of time. Additionally, BMS provided evidence that mavacamten maintains its effectiveness when taken in tandem with background beta blocker therapy. Read the complete abstract here.

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