Vera Therapeutics (VERA) said late Friday it submitted a biologics license application to the US Food and Drug Administration through an accelerated approval program for atacicept to treat adults with immunoglobulin A nephropathy, or IgAN.
The submission is based on a prespecified interim analysis of the phase 3 trial, which met its primary endpoint of reducing proteinuria at week 36. The safety profile of the drug was also favorable and comparable to placebo, the company said.
The trial is ongoing in a blinded, placebo-controlled design to assess kidney function over two years using eGFR, with completion expected in 2027, Vera said.
IgAN is a serious and progressive autoimmune disease of the kidney.
Shares of the company were up 2.5% in recent premarket activity Monday.