AstraZeneca PLC and Ionis Pharmaceuticals, Inc. obtained US Food and Drug Administration approval on 21 December for Wainua (eplontersen) in the treatment of adults with hereditary transthyretin mediated amyloidosis (ATTR) with polyneuropathy (ATTR-PN). Phase III data in ATTR cardiomyopathy are not expected until 2025, but AstraZeneca sees Wainua as an important addition to its cardiovascular disease portfolio, while Ionis views the drug as a big first step for its commercial organization.
Key Takeaways
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The US FDA approved Wainua (eplontersen) for ATTR polyneuropathy, an Ionis antisense oligonucleotide that will be co-commercialized in the US with AstraZeneca.
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The drug, which also is being developed for ATTR cardiomyopathy, is an important addition to AstraZeneca’s cardiovascular portfolio and it is the first drug that Ionis will help commercialize
Wainua is a transthyretin (TTR)-directed antisense oligonucleotide (ASO) self-administered as a once-monthly subcutaneous injection, offering a potential advantage relative to Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a TTR-directed small interfering RNA (siRNA) administered subcutaneously every three months in a doctor’s office and approved in 2022
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