New analy­sis shows in­clisir­an con­sis­ten­cy in LDL-C re­duc­tion as No­var­tis read­ies for FDA de­ci­sion

As the FDA con­tin­ues its re­view of the for­mer-The Med­i­cines Com­pa­ny, now-No­var­tis can­di­date in­clisir­an ahead of an ex­pect­ed PDU­FA be­fore the year is out, the Swiss phar­ma re­leased pooled da­ta that it hopes bol­sters the case for ap­proval.

A post-hoc analy­sis of two Phase III in­clisir­an tri­als showed con­sis­ten­cy in ef­fi­ca­cy and safe­ty among pa­tients with both hy­per­lipi­demia and ath­er­o­scle­rot­ic car­dio­vas­cu­lar dis­ease de­spite statin ther­a­py, with 99% of pa­tients show­ing greater than 30% place­bo-ad­just­ed re­duc­tion in LDL-C lev­els. The av­er­age re­duc­tion was 54.1% from base­line in the 2,300 in­di­vid­u­als be­tween the two stud­ies.

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