The FDA has approved Calliditas Therapeutics AB's (NASDAQ:CALT) Tarpeyo (budesonide) to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression.
- This indication is approved under accelerated approval.
- It has not been established whether Tarpeyo slows kidney function decline in patients with IgAN.
- Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
- Related Link: Calliditas Takes 100% Control Of Genkyotex.
- The accelerated approval is based on Phase 3 study data that showed a statistically significant 34% reduction in proteinuria from baseline vs. 5% with RASi alone (n=102) at nine months.
- The treatment effects for the primary endpoint of UPCR at nine months were consistent across key subgroups, including key demographic and baseline disease characteristics.
- It is expected that Tarpeyo will be available in the U.S. early in the Q1 of 2022.
- Related content: Benzinga's Full FDA Calendar.
- Price Action: CALT shares are up 39% at $25.90 during the premarket session on the last check Thursday.
