Novartis Oral Drug Iptacopan Submitted for Priority Review in China for C3 Glomerulopathy

Sep 23, 2024 11:36 CST Updated 11:36

Novartis

Drug Development and Manufacturing

▎WuXi AppTec Content Team Report

Today (September 23), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,NovartisNew Indication Application for Ipragliflozin Hydrochloride Capsules Proposed for Priority ReviewFor the treatment of adult patients with C3 glomerulopathy (C3G)。Ipsenat is aSpecific Complement Factor B Oral Inhibitor. For the C3G indication, the product has previously been included in the breakthrough therapy category by the CDE.

Screenshot source:CDE Official Website

Ipsicapine Capsules（iptacopan，LNP023）It is an orally administered specific complement pathway factor B inhibitor that efficiently inhibits factor B in the alternative complement pathway.It may treat diseases caused by the dysfunction of multiple alternative pathways without affecting other complement pathway-mediated immune responses to microbial invasion, thereby reducing the risk of infection for patients. This productOnce listed by the industry media Evaluate as one of the 10 products worth paying attention toPotential BlockbusterOne of the therapies.

Globally,IpcopanObtained in the United States in December 2023FDA ApprovalLaunch, Becoming a TreatmentAdult Paroxysmal Nocturnal Hemoglobinuria (PNH)The first oral monotherapy in China this year.August 8,FDA Approves AgainIpsenixIndications, used forReduce Proteinuria Levels in Adult IgA Nephropathy (IgAN) Patients, these patients are at risk of rapid disease progression.

In China,YipuPossiblePanIn April this yearApproved by NMPAThe first indication, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This yearIn August, the second indication of this product was also accepted by the CDE.. This time isYipuCanThe third marketing application of Pan in China is intended for the treatment of adult patients with C3 glomerulopathy (C3G).

According to the data disclosed by Novartis in July this year, the interim results of the published Phase 3 clinical trial APPEAR-C3G showed,In patients with C3 glomerulopathy (C3G)In China,IpsenReduced patients' proteinuria levels by 35% at 6 months of treatment compared to placebo.Novartis previously stated in publicly available information,YipuCanPan may becomeThe first potential treatment targeting the C3G alternative complement pathway.

▲YipuCanPanSignificantly reduce proteinuria levels in C3G patients (Image source: Reference [2])）

C3 glomerulopathy is a rare and severe form of primary glomerulonephritis characterized by complement dysregulation.。Publicly available data shows that the majority of patients with C3 glomerulopathy ultimately face life-altering kidney dialysis or transplantation. With no currently approved therapies, there is a significant unmet clinical need for these patients.

This timeYipuCanPanz in China is proposed to be included in the priority review, which means that the product is expected to accelerate its arrival to patients.

References:

[1] Website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Sep 23, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c

[2] Q2 2024 Results. Retrieved August 7, 2024, from https://www.novartis.com/sites/novartis_com/files/q2-2024-investor-presentation.pdf

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