Ac­celeron's PAH drug gets the FDA's red car­pet treat­ment with break­through sta­tus

Days af­ter scor­ing ex­pand­ed ap­proval for its po­ten­tial block­buster ane­mia ther­a­py, Ac­celeron has the FDA fawn­ing over its ex­per­i­men­tal drug so­tater­cept — with the US reg­u­la­tor grant­i­ng the po­ten­tial pul­monary ar­te­r­i­al hy­per­ten­sion drug break­through sta­tus.

So­tater­cept, which was grant­ed or­phan drug des­ig­na­tion by the US reg­u­la­tor last year, is en­gi­neered to re­store BM­PR-II sig­nal­ing, a key dri­ver of the dis­ease, ver­sus ex­ist­ing PAH ther­a­pies that are de­signed to di­late the pul­monary ar­ter­ies and re­duce blood pres­sure.

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