The Food and Drug Administration on Thursday approved Bristol Myers Squibb’s Camzyos, the first drug to treat the cause of an inherited form of heart failure known as obstructive hypertrophic cardiomyopathy.
Evelo Biosciences names former Alnylam, MyoKardia CEOs as strategic advisors
On Wednesday, Bristol Myers revealed topline data from the Phase III VALOR-HCM trial showing mavacamten bested placebo in reducing the need for an invasive procedure in patients with obstructive hypertrophic cardiomyopathy (oHCM), the drug giant said in a release.
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.
Mavacamten is being tested in obstructive hypertrophic cardiomyopathy, or HCM, an inherited disorder that causes the muscle walls of the heart to thicken, sometimes to the point at which they can obstruct blood flow.
It’s almost time for the FDA to make a decision on mavacamten, the myosin inhibitor at the center of Bristol Myers Squibb’s $13 billion MyoKardia buyout. With a Jan. 28 PDUFA date looming, the pharma giant is now taking the wraps off some long-term data it hopes will bolster the drug’s case for approval.
Initial public offerings of late in the biotech world have been mostly below $180 million, but the Shanghai biotech has a short yet solid history of reeling in large amounts. LianBio hit the ground running with a major $310 million series A last October, and, now, the company is raising $325 million in its Wall Street entrance at $16 per share.
Former research staffers often leave after a major buyout deal, and we might just be starting to see that with MyoKardia after its $13.1 billion merger with Bristol Myers Squibb last year as Jeff Douglas moves to Esker Therapeutics.
The EXPLORER-HCM (Evaluate Mavacamten (MYK-461) in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy) Randomized Clinical Trial has shown significant improvement in the symptoms, function, and quality of life in patients with obstructive hypertrophic cardiomyopathy (oHCM) with taking mavecamten. This comes following no major advances for treating oHCM in more than 30 years, where the primary goals of treatment are to improve patients’ health status, their symptoms, function and quality of life.
dThe program at the centerpiece of Bristol Myers Squibb’s buyout of MyoKardia just got one step closer to gaining potential FDA approval.