A couple months ahead of its PDUFA date, Bristol Myers rolls out long-term data for mavacamten
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.
Heart patients who received mavacamten in a cohort of the long-term MAVA-LTE study saw significant reductions in median levels of a hormone called NT-proBNP (58% at week 24 and 67% at week 48), Bristol Myers reported at this year’s American Heart Association conference. Higher than normal NT-proBNP levels are indicative of heart failure.
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