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Waylivra FDA Approval Status

FDA Approved: No
Brand name: Waylivra
Generic name: volanesorsen
Company: Akcea Therapeutics, Inc.
Treatment for: Familial Chylomicronemia Syndrome

Waylivra (volanesorsen) is an antisense oligonucleotide apolipoprotein C-III (ApoC-III) inhibitor in development for the treatment of familial chylomicronemia syndrome (FCS).

Development timeline for Waylivra

DateArticle
Aug 27, 2018Akcea and Ionis Receive Complete Response Letter for Waylivra from FDA
May 10, 2018FDA Advisory Committee Votes in Favor of Waylivra (volanesorsen) for Treatment of Familial Chylomicronemia Syndrome
Nov 15, 2017Akcea and Ionis Announce Acceptance of Marketing Applications in U.S., EU and Canada for Volanesorsen for the Treatment of FCS
Aug 31, 2017Akcea and Ionis Announce Submission of New Drug Application for Volanesorsen to the U.S. FDA

Further information

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