Novartis Submits New Indication Application in China for Iptacopan Capsules, a Potential Blockbuster Therapy Targeting Complement-Mediated Diseases
Novartis
Drug Development and Manufacturing
Today (August 7), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has just announced,NovartisNew Adaptation Application for Ipragliflozin Hydrochloride Capsules Accepted for Review. According to public information,Iptacopan (iptacopan, LNP023) is aSpecific Complement Factor B Oral Inhibitor, in April this year in ChinaApprovedThe first indication, for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). In April this year, the U.S. FDA also accepted the product for the treatment ofImmunoglobulin A (IgA)Nephropathy's new indication application, and grantedPriority ReviewQualification.
Screenshot source: CDE official website
Ipsen CapsulesIt is an orally administered specific alternative 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 infections in patients.IpsenOnce listed by the industry media Evaluate as one of the 10 products worth paying attention toPotential BlockbusterOne of the therapies.
In China,Ipsen's capsules have been included in the CDE's breakthrough therapy category twice, respectively for the treatment ofParoxysmal Nocturnal Hemoglobinuria (PNH)AndC3 Glomerulopathy (C3G)。
According to the Novartis official website,YipukePanCurrently, multiple Phase 3 clinical trials are underway, which are respectively aimed at evaluating its efficacy in treating IgAN, C3G, immune complex-mediated glomerulonephritis (IC-MPGN), and atypical hemolytic uremic syndrome (aHUS).In addition, two Phase 2 clinical trials for the treatment of lupus nephritis and early to intermediate age-related macular degeneration are currently underway.
Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Platform Official Website
According to the official website of the Chinese Drug Clinical Trial Registration and Information Disclosure Platform, in China,IpokPan also 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.
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