Tegsedi Clinical Development Timeline
Executive Summary
Chronicle of the development and US FDA review of Ionis Pharmaceuticals’ inotersen for treatment of polyneuropathy of hATTR amyloidosis.
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Amyloidosis Drug PROs Supported Clinical Meaningfulness Of Objective Measures
In pivotal trials for Alnylam’s Onpattro and Ionis’ Tegsedi, statistically persuasive results on a patient-reported, quality-of-life measure were needed to show the drugs had a meaningful benefit on how hATTR patients with polyneuropathy feel and function, US FDA said.
Onpattro Clinical Development Timeline
Chronicle of the development and US FDA review of Alnylam’s patisiran for polyneuropathy of hATTR amyloidosis.
Onpattro, Tegsedi Cardiac Imaging And Serum Biomarker Data Failed To Impress US FDA
Pivotal studies of the first two drugs approved for treating hereditary transthyretin-mediated amyloidosis did not provide cardiac efficacy data on how patients feel, function or survive, reviewers said; the agency approved Alnylam’s patisiran and Ionis’ inotersen for patients with the polyneuropathy form of the disease but not the cardiomyopathy form.