Akcea Therapeutics will be waiting August 2018, and expecting affirmation from FDA’s Metabolism and Endocrinology division for its treatment against a fats in the body which come as a result of lack of lipoprotein lipase enzyme.
Division of Metabolism and Endocrinology Products of the FDA will hold an advisory committee meeting to review data supporting the new drug application (NDA) for volanesorsen. The meeting should be held on May 10, 2018.
Volanesorsen is an investigational therapy for the treatment of a rare lipid disorder called familial chylomicronemia syndrome (FCS), which is characterized by the buildup of fats in the body due to a deficiency in the enzyme lipoprotein lipase.
Paula Soteropoulos, chief executive officer of Akcea Therapeutics, noted that the approval would make volanesorsen the first therapy to treat people with FCS, as there is currently no effective therapy approved. “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.”
The FDA set a PDUFA (Prescription Drug User Fee Act) goal date of August 30, 2018 for the completion of its review.
Akcea’s stocks are still near mid 20’s as it has been through February, since the jump late in January from three months below 20 period. The NASDAQ listed company’s stock quote showed $23.22 at the time of writing this.