On March 8th, 2018 the FDA Gastrointestinal Drugs Advisory Committee (GDAC) discussed the supplemental new drug application (sNDA)
On March 8th, 2018 the FDA Gastrointestinal Drugs Advisory Committee (GDAC) discussed the supplemental new drug application (sNDA) 203214 supplement 18, for XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., for the treatment of adults with moderate to severely active ulcerative colitis (UC) who have had inadequate response, loss of response, or intolerance to conventional therapies or Tumor necrosis factor (TNF) inhibitor therapy.
Tofacitinib is a small molecule inhibitor of Janus associated kinases (JAK). Tofacitinib is currently approved for adults with severely active rheumatoid arthritis (RA) (November 2012) at a dose of 5 mg BID and for adults with active psoriatic arthritis (February 2017).
1) the adequacy of efficacy data to support the use of the 10 mg BID dosing for extended induction therapy for a total of 16 weeks in patients who have not achieved “adequate therapeutic benefit” by Week 8;
2) the adequacy of the efficacy data to support the use of the 10 mg BID dosing as continuous maintenance treatment and;
3) whether additional post-marketing evaluations of efficacy and safety were warranted.
Likewise, the committee were united in support of the 10 mg twice-daily dose as maintenance therapy for patients with inadequate response, loss of response or intolerance to anti-TNF therapy.
Regarding the post-marketing efficacy study, with a split vote (7 Yes, 8 No), the committee did not recommend that the sponsor conduct a trial comparing a 10 mg BID continuous dosing regimen vs a regimen of 10 mg induction and 5mg BID as maintenance.
A decision on tofacitinib for UC is expected by June of 2018. If approved, tofacitinib would present the first orally administered agent approved for patients with moderate to severe UC.
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 firstname.lastname@example.org
Download ISS' Essential Guide to Preparing for a Meeting at the FDA White Oak Campus
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 todayContact us