Af­ter CRL, drug de­vel­op­er duo re­sub­mits its ex­per­i­men­tal drug to the FDA, look­ing to com­pete with Fab­razyme

About a year and a half af­ter get­ting turned away from the FDA, a pair of drug de­vel­op­ers is head­ing back for a sec­ond chance.

Pro­tal­ix Bio­Ther­a­peu­tics and Chiesi re­sub­mit­ted their BLA for a Fab­ry dis­ease drug, the com­pa­nies an­nounced Mon­day morn­ing, near­ly 18 months af­ter reg­u­la­tors hand­ed down a com­plete re­sponse let­ter. If every­thing goes well, the pro­gram could be ap­proved six months af­ter the FDA ac­cepts the ap­pli­ca­tion.

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