Onpattro, Tegsedi Cardiac Imaging And Serum Biomarker Data Failed To Impress US FDA
Executive Summary
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.
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Tegsedi Clinical Development Timeline
Chronicle of the development and US FDA review of Ionis Pharmaceuticals’ inotersen for treatment of polyneuropathy of hATTR amyloidosis.
Tegsedi Clinical Development Timeline
Chronicle of the development and US FDA review of Ionis Pharmaceuticals’ inotersen for treatment of polyneuropathy of hATTR amyloidosis.