Mene Pangalos, AstraZeneca EVP of BioPharmaceuticals R&D

As­traZeneca moves ear­ly for full ap­proval with an­ti­co­ag­u­lant re­ver­sal drug An­dexxa af­ter pos­i­tive PhIV da­ta

As­traZeneca is ready to take its an­ti­co­ag­u­lant re­ver­sal agent An­dexxa in­to full ap­proval from ac­cel­er­at­ed ap­proval with the FDA, the com­pa­ny an­nounced Mon­day, based on da­ta from a post-mar­ket­ing Phase IV tri­al.

The com­pa­ny is stop­ping the tri­al ear­ly based on a rec­om­men­da­tion from an in­de­pen­dent Da­ta and Safe­ty Mon­i­tor­ing Board af­ter an in­ter­im ef­fi­ca­cy as­sess­ment of 450 ran­dom­ized pa­tients showed An­dexxa’s re­ver­sal ben­e­fits ear­li­er in the study en­roll­ment than orig­i­nal­ly planned.

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