Eye­ing sec­ond Japan­ese ap­proval, Dai­ichi and Ex­elix­is an­nounce pos­i­tive piv­otal for kid­ney drug

Near­ly a year af­ter earn­ing reg­u­la­to­ry ap­proval against hy­per­ten­sion in Japan, Dai­ichi Sankyo an­nounced new pos­i­tive Phase III tri­al da­ta that could push them and the drug they de­vel­oped in col­lab­o­ra­tion with Ex­elix­is to­ward ap­proval for di­a­bet­ic nephropa­thy.

Dai­ichi test­ed Min­nebro (esax­erenone) in a dou­ble-blind tri­al against a place­bo in 455 pa­tients with di­a­bet­ic nephropa­thy and on an an­giotensin II block­er (ARB) or an­giotensin con­vert­ing en­zyme (ACE) in­hibitor. On the pri­ma­ry end­point – mi­croal­bu­min­uria re­mis­sion rate – Min­nebro out­paced a place­bo 22% to 4%. The Dai­ichi drug al­so re­duced over­all mi­croal­bu­min­uria-to-cre­a­ti­nine ra­tio by 58%, while it in­creased by 8.3% in the place­bo.

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