Calliditas Therapeutics’ Tarpeyo granted full FDA aproval for IgA nephropathy

Calliditas Therapeutics announced that the FDA has approved Tarpeyo delayed release capsules to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy – IgAN – at risk for disease progression. Tarpeyo was first approved in December 2021 under accelerated approval, based on the surrogate marker of proteinuria. Tarpeyo is now the first fully FDA-approved treatment for IgAN based on a measure of kidney function. The FDA approval is for adults with primary IgAN who are at risk of disease progression, irrespective of proteinuria levels. Tarpeyo was generally well-tolerated in the Phase 3 NefIgArd clinical trial. The most common adverse reactions in this study were peripheral edema, hypertension, muscle spasms, acne, headache, URT infection, face edema, weight increased, dyspepsia, dermatitis, arthralgia, and white blood cell count increased. Tarpeyo is available exclusively through Calliditas specialty pharmacy, Biologics by McKesson.