Page 1

FDA grants Calliditas Therapeutics Accelerated Approval of TARPEYOTM ( budesonide ) to Reduce Proteinuria in IgA Nephropathy C calliditas.se/en/fda-grants-calliditas-therapeutics-accelerated-approval-of-tarpeyo-budesonide-to-reduce proteinuria - in - iga - nephropathy - 3927 • TARPEYO ( budesonide ) delayed release capsules is the first and only treatment indicated to reduce proteinuria in adults with primary IgA nephropathy ( IgAN ) at risk of rapid disease progression , generally a urine protein - to - creatinine ratio ( UPCR ) ≥1.59 / g¹ • TARPEYO ( developed under the project name NEFECON ) is the first and only FDA - approved treatment that was specifically designed for this condition ¹ , ² 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 ) ³ Stockholm , December 15 , 2021 Calliditas Therapeutics AB ( Nasdaq : CALT , Nasdaq Stockholm : CALTX ) ( " Calliditas " ) today announced that the US Food and Drug Administration ( FDA ) has approved TARPEYO ( budesonide ) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy ( IgAN ) at risk of rapid disease progression , generally a urine protein - to - creatinine ratio ( UPCR ) ≥1.5g / g . 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.¹ This approval marks the successful transition for Calliditas to a commercial - stage biopharmaceutical company . " We are very excited to bring the first and only FDA - approved treatment to reduce proteinuria in IgAN to market , " said Renée Aguiar - Lucander , Chief Executive Officer of Calliditas . " TARPEYO represents an FDA approved product to help these patients who are at risk of rapid disease progression . " TARPEYO is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in Part A of the NeflgArd pivotal Phase 3 study , an ongoing , randomized , double - blind , placebo - controlled , multicenter study conducted to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN.¹ The effect of TARPEYO was assessed in patients with biopsy - proven IgAN , eGFR 235 mL / min / 1.73 m² , and proteinuria ( defined as either ≥1 g / day or UPCR ≥0.8 g / g ) who were on a stable dose of maximally - tolerated RAS inhibitor therapy . Patients taking TARPEYO ( n = 97 ) showed a statistically significant 34 % reduction in proteinuria from baseline vs 5 % with RASi alone ( n = 102 ) at 9 months . The treatment effects for the primary endpoint of UPCR at 9 months were consistent across key 1/7