No­var­tis to seek ac­cel­er­at­ed ap­proval for oral com­ple­ment in­hibitor in rare kid­ney dis­ease

No­var­tis said that its ex­per­i­men­tal com­ple­ment in­hibitor ip­ta­co­pan re­duced the buildup of pro­tein in the urine of pa­tients with IgA nephropa­thy sig­nif­i­cant­ly more than a place­bo, and now the Swiss phar­ma com­pa­ny plans to ap­ply for ac­cel­er­at­ed ap­proval with the FDA next year.

No­var­tis mea­sured the lev­el of pro­tein in urine — a bio­mark­er of kid­ney func­tion de­cline — at nine months for the Phase III in­ter­im analy­sis, it an­nounced Mon­day. The da­ta sug­gest that ip­ta­co­pan beat place­bo on top of sup­port­ive care for pa­tients with the rare kid­ney dis­ease.

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