No­var­tis plans for po­ten­tial ac­cel­er­at­ed ap­proval for kid­ney dis­ease drug af­ter PhI­II in­ter­im analy­sis re­sult

No­var­tis’ rare kid­ney dis­ease drug, which it ac­quired in a $3.2 bil­lion pur­chase of Chi­nook Ther­a­peu­tics in June, met the pri­ma­ry end­point of a Phase III study af­ter an in­ter­im analy­sis, the com­pa­ny an­nounced Mon­day. 

Atrasen­tan, an oral en­dothe­lin A re­cep­tor an­tag­o­nist, demon­strat­ed “su­pe­ri­or­i­ty” against place­bo at a 36-week in­ter­im analy­sis in the 340-pa­tient ALIGN study in pa­tients with IgA nephropa­thy (IgAN), a pro­gres­sive and rare kid­ney dis­ease that large­ly im­pacts young adults. IgAN is a ma­jor cause of chron­ic kid­ney dis­ease and kid­ney fail­ure as it pro­gress­es.

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