Novartis' (NVS.US) Acuratec capsules have been reported for domestic market approval for the treatment of IgA nephropathy.

On November 26, the CDE's website showed that Novartis (NVS.US) had submitted an application for the approval of its amlodipine besylate tablets in China, which is indicated for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression, and was previously included in the priority review.

Source: CDE's website

Amlodipine is an investigational, potent, selective oral ETA (endothelin A) receptor antagonist. ETA receptor activation is associated with increased proteinuria, which is related to renal damage, fibrosis, and renal function loss in IgAN. Amlodipine may be added to current supportive therapy to reduce persistent proteinuria and protect renal function in a large patient population. Preclinical models also showed that amlodipine can reduce inflammation and fibrosis in IgAN.

On May 25, Novartis announced the results of the pre-specified interim analysis of the ALIGN study in IgA nephropathy (IgAN) patients, which showed that amlodipine reduced proteinuria (as measured by the 24-hour urine protein-to-creatinine ratio [UPCR]) by 36.1% at 36 weeks compared to patients receiving supportive therapy (maximum tolerated dose and stable dose of renin-angiotensin system [RAS] inhibitors) (p<0.0001). The study also showed that amlodipine has a good safety profile, consistent with previously reported data.