Novartis Submits Third NDA in China for Oral Complement Factor B Inhibitor Iptacopan, Likely for C3 Glomerulopathy

Sep 05, 2024 10:55 CST Updated 10:55

Novartis

Drug Development and Manufacturing

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Today (September 5), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) stated,NovartisThe new indication application for Iptacopan Hydrochloride Capsules has been accepted, but the specific indication has not been disclosed. Iptacopan is a specific oral inhibitor of complement factor B, which was approved in China in April this year for its first indication to treat adult patients with paroxysmal nocturnal hemoglobinuria (PNH). This is the third marketing application for the product in China, and public data speculates that the indication may be...C3 Glomerulopathy。

Screenshot source: CDE official website

Ipsapirone 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, reducing the risk of infections 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,IpsenObtained in the United States in December 2023FDA ApprovalLaunch, Become TreatmentAdult Paroxysmal Nocturnal Hemoglobinuria (PNH)The first oral monotherapy in China this year.August 8,FDA Approves AgainIpcopanewIndications, used forReduce Proteinuria Levels in Adult Patients with IgA Nephropathy (IgAN), these patients are at risk of rapid disease progression.

In China,YipuCanPanIn 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 isYipuPossibleNovartis' Third Application for Market Approval in China.

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,EptinezumabReduced patients' proteinuria levels by 35% at 6 months of treatment compared to placebo.Novartis is expected to submit the marketing application for the treatment of C3G in the second half of 2024.Therefore, it is speculated that this timeIpkorPan ChinaThe indication for submission and marketing authorization isC3 glomerulopathy.Novartis previously stated in public documentsThe first potential treatment targeting the C3G alternative complement pathway.

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

According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, in China,YipukePan has more than 10 clinical studies ongoing, among whichPhase 3 clinical studies target indications including：Atypical Hemolytic Uremic Syndrome, C3 Glomerulopathy, IgA Nephropathy, Atypical Hemolytic Uremic Syndrome (aHUS), etc.。

References:

[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Sep 5, 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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