Novartis' Atrasentan Submitted for Priority Review in China for Treatment of IgA Nephropathy

On November 12, the CDE website showed that Novartis's Atrasentan Hydrochloride Tablets are proposed for inclusion in the priority review, indicated for reducing the risk of disease progression.Primary Immunoglobulin A Nephropathy (IgAN)Proteinuria in adult patients.

Screenshot source: Insight database

Atrasentan is a potent, selective, orally active ETA receptor antagonist under investigation.(Endothelin A)Receptor antagonists, the activation of ETA receptors leads to increased proteinuria, which is associated with renal damage, fibrosis, and loss of renal function in IgAN. Atrasentan has the potential to be added to current supportive therapies to reduce persistent proteinuria and protect renal function in a broad patient population. Preclinical models also indicate that atrasentan can reduce inflammation and fibrosis in IgAN.

On May 25, Novartis announced the treatment of IgA nephropathy with Atrasentan(IgAN)Results from the pre-specified interim analysis of the patient's Phase III ALIGN study, compared with those receiving supportive care (Maximum Tolerated Dose and Stable Dose of Renin-Angiotensin System [RAS] Inhibitors)Compared with patients who did not receive treatment, patients treated with atrasentanProteinuria at 36 Weeks(Measured by the 24-hour urinary protein-to-creatinine ratio [UPCR])Decreased by 36.1% (p<0.0001)The study also showed that atrasentan has good safety, consistent with previously reported data.

Notably, another new drug from NovartisIpecacuanha Hydrochloride CapsulesRecently, a new indication for IgAN has also been submitted for marketing approval in China.（JXHS2400053）, this drug is currently the world's first approved complement alternative pathway inhibitor for reducing proteinuria in primary IgA nephropathy (IgAN) patients at risk of rapid progression, and is expected to build on the paroxysmal nocturnal hemoglobinuria (PNH) indication already approved in China.Accelerate the Expansion of IgAN and Other Renal Indications, bringing more targeted treatment options for Chinese IgAN patients.

At this year's CIIE, Novartis introduced an innovative drug combination for IgAN treatment: Atrasentan and Iptacopan Hydrochloride Capsules.As an important part of Novartis' product pipeline in the field of kidney diseases,Atrasentan、Ipsenatide Hydrochloride Capsules, as well as another Novartis product under researchZigakibart, will jointly cover six major indications, and rewrite the current status of diagnosis and treatment of IgAN and other kidney diseases in China with a "combination approach".