FDA Accelerates Approval of the World's First IgA Nephropathy Drug

Article source: Medical Cube Info

On December 15, Calliditas announced that the FDA has accelerated the approval of budesonide (trade name: Tarpeyo, Nefecon) delayed-release capsules to reduce the risk of rapidly progressive primary IgA nephropathy (usually urinary protein to creatinine ratio ( UPCR) ≥1.

It is unclear whether budesonide can slow the decline of renal function in patients with IgA nephropathy, and subsequent approval may depend on the verification and description of clinical benefit in confirmatory clinical trials

In June 2019, Genting Xinyao reached a cooperation with Calliditas to obtain the exclusive rights to develop and commercialize Nefecon in China (including mainland China, Hong Kong, Macau and Taiwan) and Singapore, and paid Calliditas US$20 million down payment, up to 1.

The FDA approval is based on data from the global clinical study NeflgArd

Results showed that the study met the primary endpoint of Part A, which demonstrated a statistically significant reduction in the urinary protein-to-creatinine ratio, UPCR or proteinuria, after 9 months of Nefecon 16 mg once-daily treatment compared to placebo

Primary immunoglobulin A nephropathy (IgA nephropathy, IgAN, or Berger's disease) is a progressive chronic autoimmune disease that attacks the kidneys and occurs when autoantibodies recognize the galactose-deficient IgA1 molecule, which produces IgA1 immune complexes and deposited in the glomerular mesangium

Budesonide has strong glucocorticoid activity and weak mineral corticosteroid activity, and undergoes extensive first-pass metabolism