The US Food and Drug Administration (FDA) has granted full approval for Calliditas Therapeutics’ Nefecon, a treatment licensed by Everest Medicines, for adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.
This marks Nefecon as the first FDA-approved treatment for IgAN.
Nefecon is an oral, delayed-release formulation of budesonide, a corticosteroid with potent anti-inflammatory properties.
The enteric-coated capsule approval is based on its ability to significantly reduce the loss of kidney function in adults with IgAN, regardless of their proteinuria levels.
The treatment has shown a confirmed and statistically significant benefit over placebo in maintaining estimated glomerular filtration rate (eGFR) over a two-year study period.
It is a B-cell immunomodulator and is designed to address the root cause of IgAN and reduce the production of pathogenic galactose-deficient IgA1 antibodies.
Nefecon also received approval from China’s National Medical Products Administration in November last year, with results indicating a stronger effect in the Chinese subpopulation compared to the global trial participants.
In the global Phase III trial, Nefecon demonstrated a highly statistically significant and clinically relevant benefit in eGFR compared to placebo.
The treatment also showed a durable reduction in urine protein-to-creatinine ratio (UPCR) and a decrease in the proportion of patients with microhematuria. Additionally, Nefecon was generally well-tolerated among participants.
Subpopulation analysis from the NefIgArd clinical trial further highlighted a greater treatment effect in the Chinese subpopulation, showing improvements in kidney function prevention, proteinuria reduction, and microhematuria.
Everest Medicines CEO Rogers Yongqing Luo said: “We congratulate our partner on the full FDA approval of Nefecon, which confirms the drug’s capability to preserve kidney function and significantly delay disease progression.”