Novartis Submits NDA for Atrasentan in China for the Treatment of IgA Nephropathy

Nov 26, 2024 09:23 CST Updated 09:23

Novartis

Drug Development and Manufacturing

On November 26, the CDE website showed that Novartis's Atrasentan Hydrochloride Tablets had been submitted for marketing approval in China, with the indication for reducing the risk of disease progression.Primary Immunoglobulin A Nephropathy (IgAN)Proteinuria in adult patients, previouslyIncluded in the priority review.

Screenshot source:CDE Official Website

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 suggest that atrasentan can reduce inflammation and fibrosis in IgAN.

On May 25, Novartis announced the treatment of IgA nephropathy with Atrasentan(IgAN)Results of 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 urine 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.

In July this year, Atrasentan was just submitted for its first marketing application to the FDA, and currently, no country worldwide has been approved. This submission for marketing in China is expected to be approved by the end of next year at the earliest. We also noticed,The compound patent for Atrasentan in China expired in 2017.（Publication/Patent Number: CN1091768C。

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 already approved indication for paroxysmal nocturnal hemoglobinuria (PNH) in China.Accelerate the Expansion of IgAN and Other Renal Indications, bringing more targeted treatment options for Chinese IgAN patients.

In addition, Novartis has a new drug for IgA nephropathy targeting Proliferation-Inducing Ligand (APRIL) (Zigakibart), which is currently in Phase III clinical trials.

Novartis' aforementioned portfolio aims to address different drivers of IgA nephropathy, offering a variety of treatment options for this patient population.

Cover Source:Corporate Logo

Disclaimer:This article is for information sharing only and does not represent the position or viewpoint of Insight. It does not recommend or introduce any treatment plans. If you have any needs, please consult and contact正规医疗机构.

Editor: vvy

PR Article Coordination: WeChat insightxb

SubmissionWeChat: insightxb; Email: insight@dxy.cn

Diversified functions, traceable data……

Insight Database Web Version Awaits Your Experience

Click to read the original text,ImmediatelyUnlock！