No­var­tis show­cas­es Ph3 da­ta for Fab­hal­ta in IgAN as FDA grants pri­or­i­ty re­view

Months af­ter land­ing the first ap­proval for the rare dis­ease drug Fab­hal­ta, No­var­tis is on track to po­ten­tial­ly ex­pand the la­bel.

The FDA has grant­ed pri­or­i­ty re­view for the use of Fab­hal­ta in IgA nephropa­thy, a rare kid­ney con­di­tion caused by the buildup of a pro­tein known as IgA. No­var­tis an­nounced the reg­u­la­to­ry up­date in con­junc­tion with a clin­i­cal read­out where the drug re­duced pro­tein­uria, or el­e­vat­ed pro­tein in urine.

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