WebFrance - ANSM: Clinical Trial Type: EEA CTA: Trial Status: Date on which this record was first entered in the EudraCT database: 2024-11-09: Trial results: Index. A. PROTOCOL INFORMATION: B. SPONSOR INFORMATION: C. APPLICANT IDENTIFICATION: D. IMP IDENTIFICATION: D.8 INFORMATION ON PLACEBO: WebIntroduction: Inclisiran is a novel posttranscriptional gene silencing therapy that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) synthesis by RNA interference and has a potent, dose-dependent, durable effect in lowering LDL-C, and therefore is an effective drug to treat dyslipidemia, reducing the risk for acute cardiovascular (CV) events.
Leqvio European Medicines Agency
WebJan 25, 2024 · mercialize inclisiran under a license and collaboration agree-ment with Alnylam Pharmaceuticals, Inc. [8 ]. 2 Scientic Summary 2.1 Pharmacodynamics Inclisiran is a double-stranded, chemically synthesised siRNA directed against PCSK9 mRNA and conjugated with triantennary GalNAc on the sense strand [1 , 3]. Specic bind- WebMar 18, 2024 · Patients with ASCVD on maximum tolerated statin therapy were randomized to inclisiran 300 mg daily (n = 781) versus placebo (n = 780). Study drug injection was administered on day 1, day 90, day 270, and day 450. Total number of enrollees: 1,561. Duration of follow-up: 18 months. Mean patient age: 66 years. Percentage female: 30%. deschutes tribal fishing permit
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Webinclisiran should be administered initially, again at 3 months, followed by every 6 months. Treatment transition from monoclonal antibody PCSK9 inhibitors Inclisiran can be administered immediately after the last dose of a monoclonal antibody PCSK9 inhibitor. To maintain LDL-C lowering it is recommended that inclisiran is administered within WebFeb 1, 2024 · Inclisiran injection is used together with a proper diet, alone or together with other medicines (eg, statins), to treat heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) in patients who need additional lowering of their LDL cholesterol. WebDec 15, 2024 · Inclisiran is a long-acting, short-chain siRNA directed against PCSK9 protein. siRNA molecules use the natural pathway of selective gene expression silencing. … deschutes title redmond oregon