AstraZeneca and Ionis Report Positive Phase 3 Results for Eplontersen in ATTRv-PN, Plan NDA Submission to FDA

Intelligent Finance APP learned that British pharmaceutical giant AstraZeneca (AZN.US) announced that Eplontersen reached the co-primary endpoints and secondary endpoints in the Phase 3 trial for the treatment of hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).

Based on positive trial results, AstraZeneca and its partner Ionis (IONS.US) are seeking regulatory approval and now plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2022.

ATTRv-PN is expected to become the first indication for Eplontersen to receive regulatory approval.

It is reported that ATTRv-PN is a debilitating disease that causes peripheral nerve damage accompanied by motor impairment within 5 years of diagnosis, and if left untreated, patients typically die within 10 years.