Akcea Announces FDA Advisory Committee Meeting to Review Volanesorsen

Akcea Therapeutics (NASDAQ:AKCA), an affiliate of Ionis Pharmaceuticals, focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, today announced that the Division of Metabolism and Endocrinology Products of the U.S. Food and Drug Administration (FDA) will hold an advisory committee meeting to review data supporting the new drug application (NDA) for volanesorsen.

As quoted in the press release:

“Today, there is no effective therapy approved to treat people with FCS. Standard triglyceride-lowering agents are generally ineffective in lowering the extremely high triglyceride levels that cause the severe acute and chronic symptoms in people with FCS,” said Paula Soteropoulos, chief executive officer of Akcea Therapeutics. “If approved, volanesorsen would be the first therapy indicated for these patients. We look forward to reviewing the supporting data with members of the advisory committee.” The FDA set a PDUFA (Prescription Drug User Fee Act) goal date of August 30, 2018 for the completion of its review.

Click here to read the full press release.