Shots:

• The approval is based on part A of the P-III (NeflgArd) study to evaluate Tarpeyo (16mg, qd) vs PBO in patients with primary IgAN. The therapy is expected to be available in the US in Q1’22
• The trial met its 1EPs i.e., the therapy showed a 34% reduction in proteinuria from baseline over 5% with RASi alone @9mos., treatment effects of UPCR @9mos. were consistent across key subgroup including demographic & baseline disease characteristics
• TARPEYO is an oral, DR formulation of budesonide & is 1st FDA-approved treatment to reduce proteinuria for the same indication. The company launches a patient support program, Tarpeyo Touchpoints to provide access to patients treated with Tarpeyo

Ref: Calliditas | Image: Calliditas