FDA
30th October 2017

FDA Advisory Committee Supports Approval of XELJANZ/XELJANZ XR for the Treatment of Psoriatic Arthritis

On August 3rd, the FDA’s Arthritis Advisory Committee (AAC) recommended the approval of Pfizer’s tofacitinib tablets for a new indication.

FDA Advisory Committee Supports Approval of XELJANZ/XELJANZ XR for the Treatment of Psoriatic Arthritis

On August 3rd, the FDA’s Arthritis Advisory Committee (AAC) recommended the approval of Pfizer’s tofacitinib tablets for a new indication. The committee discussed supplemental new drug applications for XELJANZ (tofacitinib) tablets and XELJANZ XR extended release tablets for the treatment of adult patients with active psoriatic arthritis (PsA). Tofacitinib was first approved in 2012 at a dose of 5 mg, twice daily, to treat patients with moderate-to-active rheumatoid arthritis (RA) who did not respond to methotrexate or other non-biologic disease-modifying antirheumatic drugs. The extended release formulation was approved in 2016 at a dose of 11 mg daily.

The committee discussed the efficacy, safety and benefit-risk considerations of XELJANZ for the treatment of adults with active PsA, at the proposed dose of 5mg twice daily for XELJANZ and 11mg once daily for XELJANZ XR. At the conclusion of this meeting, 2 discussion questions and 3 voting questions were posed to the committee.

The committee voted 10 to 1 in favor of XELJANZ to treat adult patients with active psoriatic arthritis. The patient representative and temporary voting member, Diane Aronson, voted against approval and expressed concerned with the efficacy and safety; particularly the lack of inhibition of radiographic progression of the disease and infection risks.

The committee’s decision was based on demonstrated efficacy for signs and symptoms of the disease, including arthritis, enthesitis, dactylitis, and quality of life. Overall, the committee agreed with the demonstration of efficacy from the two placebo-controlled, phase III trials, which included over 800 PsA patients. They were generally comfortable with the safety results, noting that the safety profile was consistent with the current safety profile in RA patients. However, there were some concern among committee members with some adverse events and lack of evidence regarding inhibition of radiographic progression.

Known adverse effects include serious infections, malignancies, major adverse cardiovascular events, and herpes zoster. Members of the committee noted a clear risk of herpes zoster and encouraged the establishment of a strong risk mitigation program.

The totality of data did not provide substantial evidence that tofacitinib has an effect on radiographic progression, which has not been a consideration for approval of PsA drugs. Therefore, the committee warned against claims in the labeling to suggest that tofacitinib has a positive effect on radiographic progression in PsA patients, if the product were to be approved.

If approved by the FDA, tofacitinib would be the first Janus kinase (JAK) inhibitor to treat PsA. The agency is not obligated to follow its panel’s recommendation, but normally does so. The FDA’s decision on whether to approve XELJAANZ (tofacitinib) for PsA is anticipated by December 2017.

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

Do you have an upcoming Advisory Committee Meeting?

  • This field is for validation purposes and should be left unchanged.

 

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