FDA Approval of Mavacamten Delayed

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

3 thoughts on “FDA Approval of Mavacamten Delayed

  1. Anxiously awaiting approval of Mavacamten for my hypertrophic obstructive cardiomyopathy. Been waiting for about a year, since told it was severe and I’m not a good candidate for surgery due to Addisons,. Otherwise pretty healthy, but how much longer can I live like this? Also worried about the cost when and if it does become available. Someone please help me!!!

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  2. I was told I needed open heart surgery a year ago. Then when I went to my regular cardiologist he said no I should have an oblation. So the when U went to the doctor that was supposed to do the oblation. he said to w as it for the new heart medication to become available. I’ve now been waiting and stewing for a year in April. In the meantime I’m supposed to avoid stress. I just buried my 104 year old mother after being her primary care giver for 11 yrs. Interesting! No one seems to know anything about when I can get some medication for my heart other can bp meds. I’m scared!

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