Calliditas Therapeutics AB (publ) (NASDAQ: CALT) disclosed that TARPEYO (budesonide) is the first and only FDA-approved treatment for IgA nephropathy is commercially available now. The company has also announced the initial sales of TARPEYO. The company is striving hard to make TARPEYO available to patients as quickly as possible.
Calliditas is dedicated to collaborating with payers and health professionals across the country to guarantee that all patients who have been prescribed TARPEYO have accessibility to it. Calliditas has introduced TARPEYO Touchpoints, a complete patient assistance program, to help clients and their healthcare practitioners who would recommend TARPEYO. This program provides services, guidance, and resources to make it as simple as possible for patients to get treatment.
Furthermore, Calliditas revealed that the FDA had awarded TARPEYOTM (budesonide) accelerated approval on December 15, 2021, for the treatment of proteinuria in adults with primary IgA nephropathy. Those patients are at risk of rapid disease progression, which is defined as a urine protein-to-creatinine ratio (UPCR) of less than 1.5g/g. TARPEYO was created exclusively for this disease and is the first and only FDA-approved medication for it.
In addition, whether TARPEYO reduces renal function deterioration in people with IgAN has yet to be determined. Ongoing authorization for this indication could be conditional on a confirmatory clinical study demonstrating and documenting clinical benefit.