Tuesday, April 16, 2024

Celebrating a Milestone: FDA Approval of Nefecon for Primary Immunoglobulin A Nephropathy Treatment

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The US FDA has granted full approval to Calliditas Therapeutics’ Nefecon, licensed by Everest Medicines, as a treatment for adults facing primary immunoglobulin A nephropathy (IgAN) and the risk of disease progression. This milestone approval marks Nefecon as the inaugural FDA-sanctioned therapy for primary immunoglobulin A nephropathy.

Nefecon, an oral delayed-release budesonide formulation, harnesses the potent anti-inflammatory properties of corticosteroids. Its enteric-coated capsule has secured approval due to its substantial efficacy in mitigating kidney function loss among adults with IgAN, irrespective of their proteinuria levels. The treatment’s pivotal benefit rests in its ability to maintain an estimated glomerular filtration rate (eGFR) over two years, delivering a confirmed and statistically significant advantage over a placebo. Functioning as a B-cell immunomodulator, Nefecon targets the fundamental cause of IgAN by curbing the production of pathogenic galactose-deficient IgA1 antibodies.

Primary Immunoglobulin A Nephropathy

China’s Recognition Nefecon as Primary Immunoglobulin A Nephropathy Treatment

In addition to FDA approval, Nefecon gained recognition from China’s National Medical Products Administration in the preceding year, displaying amplified effectiveness among the Chinese subpopulation compared to global trial participants.

The global Phase III trial of Nefecon showcased a remarkable and clinically substantial advantage in eGFR when measured against a placebo, solidifying its potential as a groundbreaking therapeutic option for IgAN treatment.

 

Resource: Pharmaceutical Business Review, December 21, 2023

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