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Wired News – FDA’s Advisory Committee Supports Approval of Akcea’s WAYLIVRA(TM) for Treatment of Familial Chylomicronemia Syndrome

Stock Monitor: Biofrontera Post Earnings Reporting

LONDON, UK / ACCESSWIRE / May 15, 2018 / If you want access to our free research report on Akcea Therapeutics, Inc. (AKCA) ("Akcea"), all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AKCA as the Company's latest news hit the wire. On May 11, 2018, the Company, which is an affiliate of Ionis Pharmaceuticals, Inc. ("Ionis"), announced that the US Food and Drug Administration (FDA)'s Division of Metabolism and Endocrinology Products Advisory Committee voted 12-8 in favor of approving WAYLIVRATM (volanesorsen) for the treatment of people with familial chylomicronemia syndrome (FCS). Register today and get access to over 1,000 Free Research Reports by joining our site below:


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The committee's non-binding recommendation will be considered by the FDA in its review of Akcea's New Drug Application for WAYLIVRATM. The PDUFA date for completion of the review of WAYLIVRATM is August 30, 2018. Akcea submitted a New Drug Application to the FDA for volanesorsen for the treatment of FCS in August 2017.

Akcea will Work with FDA to Complete the Final Stages of Regulatory Review for WAYLIVRATM

Commenting on the approval, Paula Soteropoulos, Chief Executive Officer (CEO) of Akcea, stated that the Committee's majority vote in favor of approval is an important positive step to bring WAYLIVRATM to people with FCS who have no adequate treatment options. Soteropoulos added that the Company looks forward to working with the FDA to complete the final stages of the regulatory review for WAYLIVRATM. Akcea is committed to the FCS community and will continue to focus on bringing WAYLIVRATM, which is potentially the first and only treatment, to people living with this serious and potentially fatal disease.

FDA's EMDA Committee Voted in Favor of WAYLIVRATM after Reviewing Data from Two Phase-III Clinical Trials

The FDA's EMDA Committee voted in favor of WAYLIVRATM after reviewing data from two Phase-III clinical trials, APPROACH and COMPASS, as well as the ongoing APPROACH Open Label study for WAYLIVRATM. The results from the Phase-III APPROACH trial, the largest study ever conducted in patients with FCS, showed that patients with FCS treated with WAYLIVRATM achieved a statistically significant mean reduction in triglycerides of 77% from baseline, and a decreased risk of pancreatitis. The committee's input will be considered by the FDA in its review of the New Drug Application for WAYLIVRATM.

News reports suggest that post announcement of the news, Akcea's shares surged in pre-market trade.

WAYLIVRATM is the First Drug to Demonstrate Substantial Triglyceride Lowering in Clinical Trials in Patients with FCS

Brett P. Monia, Chief Operating Officer (COO) at Ionis, stated that people with FCS have severely elevated triglycerides, which may lead to multiple severe daily and chronic symptoms, such as abdominal pain and increased risk for pancreatitis, which can be fatal. WAYLIVRATM is the first drug to demonstrate substantial triglyceride lowering in clinical trials in people with FCS. Monia added that WAYLIVRATM illustrates how the Company's antisense technology can create targeted drugs for people living with severe diseases who currently have no available therapeutic options.


WAYLIVRATM, a product of Ionis' proprietary antisense technology, is under regulatory review in the US, the EU, and Canada as a treatment for FCS. The US and the EU regulatory agencies have granted an Orphan Drug Designation (ODD) to WAYLIVRATM for the treatment of FCS. WAYLIVRATM is designed to reduce the production of ApoC-III, which is a protein produced in the liver that plays a central role in the regulation of plasma triglycerides and may also affect other metabolic parameters. It is also currently in Phase-III clinical development for the treatment of patients with familial partial lipodystrophy, or FPL. Akcea anticipates reporting top-line data from this study in 2019.

About Familial Chylomicronemia Syndrome (FCS)

FCS is a rare, life-threatening disease that prevents the body from digesting fats. FCS is a genetic disorder, and is caused by an impaired function of the enzyme lipoprotein lipase (LPL) and characterized by severe hypertriglyceridemia and a risk of unpredictable and potentially fatal acute pancreatitis. In addition to pancreatitis, FCS patients are at risk of chronic complications due to permanent organ damage. They can experience daily symptoms including abdominal pain, generalized fatigue, and impaired cognitions that affect their ability to work. There is no effective therapy for FCS currently available.

About Akcea Therapeutics, Inc. and Ionis Pharmaceuticals, Inc.

Founded in 2015 and headquartered in Cambridge, Massachusetts, Akcea is a development and commercialization organization focused on helping patients with serious diseases. The Company is an affiliate of Ionis, which is a leading company in RNA-targeted drug discovery and focused on developing drugs for patients who have the highest unmet medical needs. Akcea is advancing a mature pipeline of six novel drugs, including TEGSEDITM (inotersen), WAYLIVRATM (volanesorsen), AKCEA-APO(a)-LRx, AKCEA-ANGPTL3-LRx, AKCEA-APOCIII-LRx, and AKCEA-TTR-LRx, all with the potential to treat multiple diseases. All six drugs were discovered by and are being co-developed with Ionis, and are based on Ionis' proprietary antisense technology.

Stock Performance Snapshot

May 14, 2018 - At Monday's closing bell, Akcea Therapeutics' stock fell 5.34%, ending the trading session at $22.53.

Volume traded for the day: 989.34 thousand shares, which was above the 3-month average volume of 410.67 thousand shares.

Stock performance in the last three-month – up 4.84%; previous six-month period – up 28.96%; and year-to-date - up 29.78%

After yesterday's close, Akcea Therapeutics' market cap was at $1.67 billion.

The stock is part of the Healthcare sector, categorized under the Biotechnology industry. This sector was up 0.7% at the end of the session.


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