Posted by Michael Wonder on 22 Jun 2023
Calliditas Therapeutics submits supplemental new drug application to US FDA for full approval of Tarpeyo
21 June 2023 - Calliditas Therapeutics today announced the submission of a supplemental new drug application to the US FDA seeking full approval of Tarpeyo (budesonide) delayed release capsules for the entire study population from the Phase 3 NeflgArd study.
Tarpeyo is currently approved under accelerated approval to reduce proteinuria in adults with primary IgA nephropathy at risk of rapid disease progression, generally a urine protein to creatinine ratio ≥1.5g/g.
