Patisiran, an siRNA, was approved by the FDA in August 2018 (Figure 3B) as the first siRNA therapeutic agent. Prior to its approval, patisiran had earned fast-track and priority review status in addition to orphan drug designation due to its mechanism and function and the rarity of the dise...
Onpattro has been granted Fast Track, Priority Review and Breakthrough Therapy, and Orphan Drug designations. 药物别名 Patisiran 治疗类别 Antisense Elements (Genetics);Diagnostic Uses of Chemicals;Laboratory Chemicals;Molecular Probes;Nucleic Acid Probes;Nucleic Acids;Nucleic Acids, Nucleotides, and ...
2018年8月10日,全球首个小干扰 RNA(siRNA)药物 Onpattro(通用名为 patisiran) 经美国 FDA 批准上市[1]。Onpattro 是由美国奥尼兰姆(Alnylam)公司研发,用于治疗成人患者因转甲状腺素蛋白淀粉样变性(hATTR,也称家族性淀粉样多发性神经病变)引起的神经损伤,也是第一个用于治疗 hATTR的药物。Onpattro 通过静脉内输注...
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY) today announced the positive outcome of the U.S. Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting to discuss the supplemental New Drug...
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Onpattro (patisiran lipid complex) 泛型说明文档说明书 Proprietary & Confidential © 2019 Magellan Health, Inc.Onpattro (patisiran lipid complex)(Intravenous)Document Number: IC-0379 Last Review Date: 10/01/2019 Date of Origin: 09/05/2018 Dates Reviewed: 09/2018, 10/2019 I.Length of ...
The FDA granted this application Fast Track, Priority Review and Breakthrough Therapy designations. Onpattro also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.
by FDA in 2018 for the treatment of hereditary transthyretin amyloidosis and became the first successful clinical application of siRNA drug. This article introduces and analyzes Onpattro from four aspects： formulation， technology， clinical advantages and market conditions， and makes a brief review ...
Review article Emerging therapeutic avenues in cardiac amyloidosis European Journal of PharmacologyJournal2023,European Journal of Pharmacology VaishnaviGolatkar,Lokesh KumarBhatt 4.2.2.1.1Patisiran Patisiranis an RNA interference (RNAi) therapeutic, approved by the FDA for the treatment of ATTRvpolyneuropathy...
2018年8月10日,全球首个小干扰RNA(siRNA)药物Onpattro(通用名为patisiran)经美国FDA批准上市[1].Onpattro是由美国奥尼兰姆(Alnylam)公司研发,用于治疗成人患者因转甲... M Brooks - 《Cardiology News》 被引量: 0发表: 2023年 A Review of Patisiran (ONPATTRO) for the Treatment of Polyneuropathy in Peo...