Novartis to seek approvals in two rare kidney diseases after positive Phase 3 trials

No­var­tis is build­ing out its rare kid­ney dis­ease port­fo­lio with two batch­es of Phase 3 da­ta at the Eu­ro­pean Re­nal As­so­ci­a­tion con­fer­ence, tout­ing pos­i­tive re­sults for an in­ves­ti­ga­tion­al drug in IgA nephropa­thy and for its drug Fab­hal­ta in C3 glomeru­lopa­thy.

In an in­ter­im analy­sis of the IgA nephropa­thy tri­al, called ALIGN, pa­tients on No­var­tis’ ex­per­i­men­tal drug atrasen­tan saw a 36.1% re­duc­tion in pro­tein­uria, a mea­sure of pro­tein in the urine (p<0.0001). Pro­tein­uria lev­els are a bio­mark­er used to track the kid­ney dis­ease pro­gres­sion, and have been used in IgAN tri­als to sup­port ap­proval, ac­cord­ing to No­var­tis.

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