Capricor's deramiocel
for Duchenne cardiomyopathy
Over the last year or so, a cell therapy from Capricor Therapeutics has been swept up in the kind of regulatory turmoil the White House seems intent on bringing to halt.
Capricor’s cell therapy is for the heart muscle weakness, or cardiomyopathy, that’s a leading cause of death in people with the rare disease Duchenne muscular dystrophy. Called deramiocel, it’s derived from a special type of heart cell known to help preserve function.
Capricor initially sought an FDA clearance largely on Phase 2 results showing the treatment helped improve measures of upper limb function as well as the heart’s ability to pump blood. It claimed to have aligned with agency officials in putting together deramiocel’s approval package, and was therefore taken by surprise when the FDA rejected its application last July.
