Alnylam announces that Onpattro has been approved by MHLW for the treatment of amyloid degeneration partner polyneuropathy
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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recently, Alnylamcompany(http://announced that its Onpattro (MHLW) has been approved by Japan's Ministry of Health, Labour and Welfare (MHLW) to treat hereditary-transthyroxinetic (hATTR) amyloid amyloid neuropathyon Onpattro
Onpattro is an intravenous lym on RNAidrug(http://that blocks the production of thyroxine-carrying proteins (TTRs) through targeted and silent messenger RNA, which may help reduce deposition and promote the removal of TTR amyloid proteins in the peripheral tissues and restore the function of these tissuesin the United States and the European Union, Onpattro was approved on August 10, 2018 and August 30, 2018, becoming the first RNAi drug to be approved for the year in 20 yearsOnpattro's approval is based ondata from theTrial(http:// of APOLLO, a Phase III clinical studyThis is a randomized, double-blind, placebo-controlled, global study conducted in patients with hATTR amyloid degeneration with multiple neuropathy to assess the effectiveness and safety of Onpattrostudiesresults showed that Onpattro achieved excellent therapeutic results, reaching the main and all secondary endpoints of the study: Compared to placebo, Onpattro improved polyneuropathy, quality of life, daily activity, walking ability, nutritional status, and autonomic neurological symptomsin addition,, an analysis of cardiac subgroup(http://in patients with myocardial strain (56% of the total number of patients in the study) showed a significant improvement in cardiac structure and functional exploratory endpoints compared to placebosafety
the incidence and severity of adverse events in the Onpattro treatment group and the placebo group were similar, and the incidence of edema and infusion-related reactions around the Onpattro treatment group was higher, but usually mild to moderate
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