Calliditas Therapeutics (CALT) TARPEYO Granted FDA Approval

Calliditas Therapeutics AB (Nasdaq: CALT) announced that the 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 ≥35 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 subgroups, including key demographic and baseline disease characteristics.1

The most common adverse reactions (≥5%) in this study were hypertension, peripheral edema, muscle spasms, acne, dermatitis, weight increase, dyspnea, face edema, dyspepsia, fatigue, and hirsutism. Please see additional Important Safety Information below.

Richard Lafayette M.D., Professor of Medicine at Stanford University and the Director of the Stanford Glomerular Disease Center commented, "IgAN is a tough diagnosis for many patients, and it can progressively lead to the need for dialysis and/or kidney transplantation. The FDA approval of TARPEYO now offers disease-specific treatment for patients with this complicated disease."

Richard Philipson, Calliditas Chief Medical Officer added, "TARPEYO was developed to target a root cause of IgAN. The FDA's approval of TARPEYO demonstrates our unwavering dedication to patients suffering from IgAN. We would like to thank the patients, researchers and clinical staff who participated in the studies of TARPEYO."

Bonnie Schneider, Director and Co-Founder of the IGA Nephropathy Foundation of America commented," It has been a difficult journey not only for our family but for all the IgA nephropathy patients we serve. Having this disease specific option has our community very excited."

It is expected that TARPEYO will be available in the U.S. early in the first quarter of 2022. To assist patients and their healthcare providers who would prescribe TARPEYO, Calliditas is launching a comprehensive patient support program, TARPEYO Touchpoints™. This program offers services, assistance, and resources designed to help patients access treatment as easily as possible. To learn more visit TARPEYOTouchpoints.com or call 1-833-444-8277.

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