According to the financial news app Zhitong, on November 12, the official website of CDE shows that Novartis (NVS.US) hydrochloride Acurastan tablets are intended to be included in priority review, indicated for reducing proteinuria in adult patients with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression.

Public information shows that Acurastan is an investigational potent selective oral endothelin-A (ETA) receptor antagonist. Activation of ETA receptors can lead to elevated proteinuria, which is related to kidney damage, fibrosis, and loss of kidney function in IgAN. Acurastan may be added to current supportive therapies to reduce persistent proteinuria and protect the kidney function of a wide range of patients. Preclinical models also suggest that Acurastan can reduce inflammation and fibrosis in IgAN.

It is worth noting that Novartis's another new drug, Yipkope hydrochloride capsules, has recently submitted a new indication for IgA nephropathy (IgAN) for domestic market approval (JXHS2400053). The drug is currently the world's first complement alternative pathway inhibitor approved to reduce proteinuria in primary IgA nephropathy (IgAN) at risk of rapid progression, and is expected to accelerate the expansion of indications in the field of IgAN and other kidney diseases, building on the already approved indication for paroxysmal nocturnal hemoglobinuria (PNH) in China, to bring more targeted treatment options for Chinese IgAN patients.