BMS heart drug, center of its $13B MyoKardia buyout, hit by FDA delay

Just days ago, Bristol Myers Squibb was touting new data for the targeted heart drug mavacamten. Now, the Big Pharma has announced that the FDA has extended the decision date for the drug, which was nabbed through the $13 billion buyout of MyoKardia.

BMS announced that the date has slid from Jan. 28, 2022, to April 28, 2022. The details were slim, but the company said the FDA notified them Thursday that they needed more time to consider an update to the Risk Evaluation Mitigation Strategy, or REMS, program.

The drug was not being reviewed under a speedy process, which can chop months off the normal assessment time for a new drug; the FDA accepted mavacamten in March this year, meaning should it take until late April to make a decision, it would have taken more than a year.

The company is seeking approval for mavacamten in symptomatic obstructive hypertrophic cardiomyopathy, or HOCM, an inherited disorder that causes the muscle walls of the heart to thicken, sometimes to the point at which they can obstruct blood flow.

REMS programs are sometimes required by the FDA for medications that have serious safety concerns to ensure the benefits of treatment outweigh the risks. These programs reinforce safe use requirements and inform healthcare providers of the relevant risks.

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For instance, a REMS program for BMS’ lymphoma med Breyanzi was approved in February. The program aims to mitigate the risk of cytokine release syndrome and requires clinics administering the medication to have access to the immunosuppressant drug Actemra in case of the overactive immune response. Actemra is made by Roche’s Genentech unit.

Mavacamten's application was accepted by the FDA in March. BMS noted at the time that HCM is associated with an increased risk of atrial fibrillation, stroke, heart failure and sudden cardiac death. BMS did not mention the REMS program when announcing the acceptance, but, in a press release about the FDA delay now, said the program was included in the application.

Neither new studies nor new data have been requested by the FDA, according to BMS.

BMS is also developing mavacamten for other types of heart disease, including non-obstructive HCM and heart failure with preserved ejection fraction. The company is also testing whether the drug can spare patients from surgical procedures.