FDA
14th December 2015

FDA Panel Supports Approval of Lesinurad (Zurampic) for Gout

In October, the Arthritis Advisory Committee (AAC) voted 10 to 4 in favor of approval of lesinurad (Zurampic, AstraZeneca) 200.

FDA Panel Supports Approval of Lesinurad (Zurampic) for Gout

In October, the Arthritis Advisory Committee (AAC) voted 10 to 4 in favor of approval of lesinurad (Zurampic, AstraZeneca) 200 mg once daily for the treatment of gout-associated hyperuricemia, in combination with a xanthine oxidase inhibitor (XOI).

Furthermore, the committee voted unanimously that the company presented substantial evidence in favor of the drug’s efficacy. However, a split vote resulted when the panel was asked about whether substantial evidence of the drug’s safety was presented (7 yes, 6 no, 1 abstention).

The vote followed a discussion around data from three multiregional, randomized, double-blind, placebo-controlled, parallel group trials that enrolled 1537 patients and evaluated lesinurad (200-mg and 400-mg doses) in combination with an XOI (allopurinol or febuxostat). Results showed that lesinurad significantly improved sUA levels, the primary endpoint, but it did not demonstrate clinical efficacy for the secondary endpoints of flare occurrence, tophus reduction, or improved physical function.

Panel member, Andreas M. Reimold, MD, from Dallas VA Medical Center, Texas noted “I…agree with a lot of the sentiments that we need a good phase 4 study to look at comorbidities and look at real-world adverse events.”

Lesinurad works by decreasing the production of uric acid and increasing its excretion. The proposed dosing regimen is 200 mg orally once daily. If the FDA approves lesinurad, it will be the first selective uric acid reabsorption inhibitor in the United States.

The FDA is not bound by their advisory committees’ recommendations; however, they are often followed.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs 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.

Do you have an upcoming Advisory Committee Meeting?

White Oak Gude

 

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