FDA Grants Calliditas Accelerated Approval Of Tarpeyo To Reduce Proteinuria In IgA Nephropathy

(RTTNews) - The U.S. Food and Drug Administration has approved Tarpeyo or budesonide delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy or IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) =1.5g/g. The indication is approved under accelerated approval, Calliditas Therapeutics AB (CALT) said in a statement.

CALT closed Wednesday regular trading at $18.64 up $1.99 or 11.95%. In the after-hours trade, the stock further gained $10.02 or 53.73%.

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.

The company expects that Tarpeyo will be available in the U.S. early in the first quarter of 2022.

IgAN is a rare, progressive autoimmune disease, which has a high unmet need with more than 50% of patients potentially progressing to end-stage renal disease (ESRD).