FDA Advisory Committee Votes in Favor of WAYLIVRA for Treatment of Familial Chylomicronemia Syndrome
AKCEA THERAPEUTICS (AKCA)
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Source: GlobeNewswire
CAMBRIDGE, Mass. and CARLSBAD, Calif., May 10, 2018 (GLOBE NEWSWIRE) -- Akcea Therapeutics, Inc. (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, Inc., and Ionis Pharmaceuticals, Inc. (NASDAQ:IONS) today announced that the U.S. Food and Drug Administration’s (FDA) Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 to support approval of WAYLIVRATM (volanesorsen) for the treatment of people with familial chylomicronemia syndrome (FCS). The committee’s non-binding recommendation will be considered by the FDA in its review of Akcea’s New Drug Application for WAYLIVRA. The PDUFA date for completion of the review of WAYLIVRA is August 30, 2018. “We thank the committee members for their time and their comments today. The Committee’s majority vote in favor of approval is an important positive step to bring WAYLIVRA to people with FCS who have no adequate treatment options,” said Paula Soteropoulos, chief executive officer of Akcea Therapeutics. “We
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