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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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