Marathon's cheap, old steroid breezes through the FDA for Duchenne MD, and gets priced at $89K

For a sim­ple sys­temic steroid that is cheap and eas­i­ly avail­able out­side the US, de­flaza­cort has re­ceived un­usu­al­ly care­ful sup­port from the FDA, breez­ing through a reg­u­la­to­ry process that has be­dev­iled sev­er­al de­vel­op­ers try­ing to ad­dress the root cause of the dis­ease.

De­flaza­cort won a pri­or­i­ty re­view from the agency as a new ther­a­py for Duchenne mus­cu­lar dy­s­tro­phy — cut­ting four months off the reg­u­la­to­ry process — along with an or­phan drug des­ig­na­tion and rare pe­di­atric dis­ease sta­tus. And to­day, the FDA hand­ed Marathon Phar­ma­ceu­ti­cals a green light to start mar­ket­ing the drug to all boys 5 and old­er whose lives are be­ing slow­ly de­stroyed by the dis­ease.

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