Eplontersen fda approval

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Actual: eplontersen to challenge Alnylam's Amvuttra AstraZeneca/Ionis's Eplontersen Shows Competitive Efficacy In ATTR Polyneuropathy At 66 Weeks. US FDA Approval
4.9 rating 2025-04-24
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Eplontersen (Wainua) was approved by the FDA to treat polyneuropathy associated with hereditary transthyretin-mediated amyloidosis (ATTR) in adults.

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The FDA has approved eplontersen (Wainua; AstraZeneca, Ionis Pharmaceuticals) for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis (ATTRv-PN) in adults. This approval makes eplontersen the only medicine to be approved for the treatment of ATTRv-PN that can be self-administered with an auto-injector.

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In January 2024, eplontersen was granted Orphan Drug Designation in the U.S. by the FDA. In addition to the NEURO-TTRansform study, eplontersen

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FDA approved for the treatment of the cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM). Eplontersen

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Wainua will enter the US market in January 2024 after positive Phase III data landed it an FDA approval for ATTRv-PN (eplontersen) for a

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The FDA has approved eplontersen (Ionis, AstraZeneca), a ligand-conjugated antisense oligonucleotide, for the treatment of adult patients with hereditary

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(Nasdaq: IONS) announced today that the U.S. Food and Drug Administration (FDA) has approved Ionis and AstraZeneca's WAINUA (eplontersen) for

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Wainua (eplontersen) injection, for subcutaneous use. US Food and Drug Administration (FDA) approval information. Revised December 2024.

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WAINUA (eplontersen) injection, for subcutaneous use This label may not be the latest approved by FDA. For current labeling information, please visit https

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