FDA grants full approval to Calliditas for IgA nephropathy drug

Calliditas Therapeutics has secured FDA approval for Tarpeyo (budesonide) delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN).

Tarpeyo, initially granted accelerated approval in December 2021, is now the sole FDA-approved therapy for IgAN determined by kidney function. The phase 3 NefIgArd clinical trial provided the basis for this milestone, offering evidence of Tarpeyo general tolerability.

Known as Nefecon during its investigational phase, Tarpeyo is a B-cell immunomodulator designed to target the source of IgAN and reduce the production of pathogenic antibodies causing the disease. The FDA approval is applicable to adults with primary IgAN at risk of disease progression, irrespective of proteinuria levels. Tarpeyo efficacy was demonstrated by sustained reductions in proteinuria and a clinically significant reduction in the loss of eGFR, potentially slowing the progression towards dialysis or transplant care.

The drug is available exclusively through Calliditas specialty pharmacy, Biologics by McKesson. Prescribers must complete an enrollment form to connect patients with benefits, including financial aid programs, care navigation, and at-home, next-day delivery. Calliditas says the program aims to eliminate cost barriers to care, with 97% of patients paying less than $10 per prescription and 88% paying nothing at all.