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AstraZeneca, Ionis Win A Key US FDA Approval With Wainua For ATTR Polyneuropathy

Drug Launches In January Under Co-Commercialization Deal

 
• By Mandy Jackson

AstraZeneca adds an important product to its cardiovascular, renal and metabolism (CVRM) portfolio and Ionis gains the first drug it will commercialize as it prepares for its first wholly owned launch.

FDA Approved text on white notepad paper near folders
Wainua is the first patient-administered drug for ATTR-PN • Source: Shutterstock

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

  • The US FDA approved Wainua (eplontersen) for ATTR polyneuropathy, an Ionis antisense oligonucleotide that will be co-commercialized in the US with AstraZeneca.

  • The...

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...

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