Ionis: FDA to Review Eplontersen in ATTRv-PN

By Colin Kellaher

Ionis Pharmaceuticals Inc. on Tuesday said the U.S. Food and Drug Administration will review its application seeking approval of its eplontersen drug candidate for the treatment of the rare multisystemic disease hereditary transthyretin-mediated amyloid polyneuropathy, or ATTRv-PN.

The Carlsbad, Calif., pharmaceutical company said the FDA set a target action date of Dec. 22 for the application, adding that the agency indicated that it isn't planning to hold an advisory committee meeting.

ATTRv-PN is a debilitating disease that leads to peripheral nerve damage with motor disability within five years of diagnosis and is generally fatal within a decade without treatment.

Ionis and Anglo-Swedish drugmaker AstraZeneca PLC in late 2021 inked an agreement to jointly develop and commercialize eplontersen in the U.S., with AstraZeneca developing and commercializing the drug in the rest of the world with the exception of Latin America.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 07, 2023 07:47 ET (12:47 GMT)

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