FDA
17th October 2013

FDA Advisory Committee Votes Against Expanded Indication for Vascepa

The Endocrinologic and Metabolic Drugs Advisory Committee declined to recommend an expanded indication for Amarin Pharmaceutical’s.

FDA Advisory Committee Votes Against Expanded Indication for Vascepa

The Endocrinologic and Metabolic Drugs Advisory Committee declined to recommend an expanded indication for Amarin Pharmaceutical’s Vascepa (icosapent ethyl). The panel voted 9-2 yesterday against approval of the drug for the proposed new indication that would allow it to be available to a much broader patient population.

Vascepa is currently indicated only for the relatively small number of people with severe hypertriglyceridemia (>500 mg/dl). The new indication would include individuals who have elevated triglycerides (>200 mg/dl) and existing cardiovascular disease (CVD) or those who are susceptible to CVD.

Vascepa is a purified ethyl ester of eicosapentaenoic acid (EPA) derived from fish oil. EPA, along with docosahexaenoic acid (DHA) and alpha-linolenic acid are collectively referred to as omega-3 fatty acids.

The supplemental new drug application (sNDA) for the indication was based on the ANCHOR trial, which demonstrated that Vascepa did in fact lower triglycerides in the target patient population. However, FDA review raised some issues that made it difficult to precisely measure Vascepa’s triglyceride-lowering effect. Furthermore, the panel was not convinced that lowering triglycerides would automatically lead to a reduced risk of coronary heart disease or death. Dr. David Cooke, clinical director of pediatric endocrinology at Johns Hopkins University School of Medicine and a panelist, said it “has not yet been proven” that Vascepa, or any medication that lowers blood fats, except statins, decreases cardiovascular risk.

The panel recommended waiting for the results of the large ongoing Vascepa outcomes trial,  REDUCE-IT, before coming to a conclusion. This ongoing trial has enrolled more than 6,000, out of an eventual 8,000, patients and is expected to shed light on whether Vascepa actually cuts cardiovascular risk. Amarin said the trial should be completed in 2016.

The FDA is not bound to follow the recommendations of its advisory panels but typically does.

 

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComms per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net

Interested in learning about ISS’ expert approach to Advisory Committee Meetings? Click below in order to find out for yourself! 

Generic Blog CTA for Ad Comm Approach

 

Recent Related Articles

Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission
01 July 2020
Best Tips for Medical Device Manufacturers to Write a Compelling Substantial Equivalence Section for their FDA 510k Submission

Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more

Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices
25 June 2020
Evolving FDA Thinking on Advisory Committee Meetings Related to Foods, Drugs, and Devices

FDA advisory committee meetings are important regulatory events for many manufacturers on the path to marketing approval. These meetings can quite literally result in the approval or rejection of a product based on the panel’s vote. Read more

NDA vs. OTC Monograph: Which Pathway is Right for You?
22 June 2020
NDA vs. OTC Monograph: Which Pathway is Right for You?

One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more

4 Problems Importing Rapid Antibody Tests for Coronavirus
19 June 2020
4 Problems Importing Rapid Antibody Tests for Coronavirus

US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more

Let’s work together

The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today

Contact us