On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees.
On January 11th, 2019, Takeda Pharmaceuticals appeared before a joint session of the Arthritis Advisory and the Drug Safety and Risk Management Advisory Committees. They were seeking approval for their supplemental new drug application for Uloric tablets (sNDA 021-856).
Uloric, a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout, was FDA-approved in 2009. Prior to this approval, Uloric was rejected twice due to concerns about cardiovascular safety that arose during clinical trials.
As a stipulation of the 2009 approval, the FDA requested an extensive post-marketing safety trial to evaluate the cardiovascular safety which was the subject of this committee meeting. The study is entitled Cardiovascular Safety of Febuxostat and Allopurinol in Patients with Gout and Cardiovascular Morbidities (CARES).
In this meeting, there were four discussion questions and one voting questions. The vote addressed whether a patient population exists in which the benefit-risk profile for Uloric is favorable for the treatment of hyperuricemia in patients with gout. It resulted in 19 YES, 2 NO, and 1 ABSTENTION.
The majority of the committee members felt that the benefit/risk ratio was favorable for the treatment of hyperuricemia in patients with gout. However, they also suggested stronger risk labeling, a boxed warning, a second-line therapy indication, an update to the gout treatment guidelines by the American College of Rheumatology (ACR), and “Dear Healthcare Provider” letters to communicate the risk to patients and their providers so they can make an informed decision on a care plan. One committee member disagreed with the approval and expressed concerns that the drug causes death in some patients.
The agency is not obligated to follow its panel’s recommendation, but normally does so.
Following the recommendations by the joint committee, on February 21, 2019 the FDA updated the prescribing information to require a Boxed Waring and a new patient Medication Guide. In addition, they limited the approved uses of Uloric to patients who are not treated effectively or experience severe side effects with allopurinol.
ISS has almost two decades 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.
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
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
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
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
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