Ionis announces FDA acceptance of New Drug Application for eplontersen for the treatment of hereditary transthyretin-mediated amyloid polyneuropathy

Submitted by admin on March 8, 2023 - 9:47am

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PR Newswire

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35-week data included in the filing demonstrated a statistically significant and clinically meaningful change from baseline for co-primary and secondary endpoints compared to external placebo group
Eplontersen previously granted Orphan Drug Designation for transthyretin-mediated amyloidosis
FDA assigns PDUFA action date of Dec. 22, 2023

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