AstraZeneca, Ionis application for nerve damage therapy OKd by FDA

 

• 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

Ionis Pharmaceuticals (Nasdaq: IONS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a New Drug Application (NDA) for eplontersen, an investigational antisense medicine for the treatment of people living with hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN). The application has been given a Prescription Drug User Fee Act (PDUFA) action date of Dec. 22, 2023.

https://finance.yahoo.com/news/ionis-announces-fda-acceptance-drug-120500628.html