Calliditas Therapeutics has announced the FDA has approved its Tarpeyo (budesonide) delayed release capsules 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 yet been established whether the therapy slows kidney function decline in patients with IgAN. Continued approval may be contingent on demonstration of clinical benefit in a confirmatory clinical trial.
“We are very excited to bring the first and only FDA-approved treatment to reduce proteinuria in IgAN to market,” said Renée Aguiar-Lucander, CEO of Calliditas. “Tarpeyo represents an FDA approved product to help these patients who are at risk of rapid disease progression.”
The therapy is approved under accelerated approval based on achieving its primary endpoint of reduction in proteinuria in an ongoing, randomized, double-blind, placebo-controlled, multicenter study. The therapy’s effect was assessed in patients with biopsy-proven IgAN and proteinuria who were on a stable dose of maximally-tolerated RAS inhibitor therapy.
Patients in the treatment group showed a statistically significant 34% reduction in proteinuria from baseline vs 5% with RASi alone at 9 months.
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.
Richard Lafayette, Professor of Medicine at Stanford University and the Director of the Stanford Glomerular Disease Center said: “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 CMO 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.”
