Novartis (NVS.US)'s ataxentan hydrochloride tablets are marketed in China and are indicated for IgA nephropathy

The Zhitong Finance App learned that on November 26, CDE's official website showed that Novartis (NVS.US) ataxanthin hydrochloride tablets were marketed in the domestic press. The indication is proteinuria in adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression, which has previously been included in the priority review.

Screenshot source: CDE official website

Atracentan is a potent and selective oral ETA (endothelin A) receptor antagonist under investigation. Activation of ETA receptors causes elevated proteinuria, which is associated with kidney damage, fibrosis, and loss of renal function in IgAN. Atracentane may be added to current supportive therapies to reduce persistent proteinuria and protect renal function in a broad patient population. Preclinical models have also shown that ataxentan can reduce inflammation and fibrosis in IgAN.

On May 25, Novartis announced the scheduled midterm analysis of the phase III ALIGN study of patients with IgA nephropathy (IgAN) with ataxentane. Compared with patients receiving supportive treatment (maximum tolerated dose and stabilized dose of renin-angiotensin system [RAS] inhibitors), patients treated with ataxentan decreased proteinuria (measured by a 24-hour urine protein to creatinine ratio [UPCR]) by 36.1% (p<0.0001) at 36 weeks. The study also showed that atracentan has good safety, which is consistent with previously reported data.