The US Food and Drug Administration (FDA) has accepted for review the Pfizer Inc's supplemental New Drug Application (sNDA) for Xeljanz (tofacitinib citrate) 5 mg and 10 mg tablets, a Janus kinase (JAK) inhibitor, the first in a new class of oral medicines being investigated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in October 2015 for the sNDA.
The submission to the FDA is based on data from the phase 3 Oral treatment Psoriasis Trials (OPT) Programme, a global, multi-study, comprehensive clinical development programme that consisted of five studies (including an ongoing long-term extension study), designed to evaluate oral Xeljanz 5 mg and 10 mg twice daily in patients with moderate to severe chronic plaque psoriasis. With more than 3,600 adult psoriasis patients enrolled across 36 countries, the OPT programme has yielded one of the largest databases for a potential psoriasis indication at the time of registration.
Xeljanz is a small molecule that targets the JAK pathway, a signaling pathway inside the cells, thought to play a role in chronic inflammatory responses.
“This regulatory milestone demonstrates our commitment to the research of chronic inflammatory diseases with the goal of developing therapies, such as Xeljanz, that can help address unmet medical needs for patients,” said Steve Romano, MD, SVP and Head, Global Medicines Development for the Pfizer Global Innovative Pharmaceutical business. “We continue to play a leadership role in the evaluation of JAK inhibition across chronic inflammatory diseases, such as psoriasis.”
Xeljanz is approved in 37 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA). In the United States, Xeljanz 5 mg tablets are approved for the treatment of adults with moderate to severe RA who have had an inadequate response or intolerance to methotrexate (MTX). The benefit:risk profile of Xeljanz in RA has been characterized through the study of 6,192 RA patients representing 16,800 patient years of exposure in the global clinical development programme for Xeljanz in moderate to severe RA.
Psoriasis is a chronic, immune-mediated inflammatory skin disease, affecting the skin and other parts of the body, such as nails. It affects approximately two-to-three per cent of people worldwide and 7.4 million in the United States. The most common form is plaque psoriasis, which affects about 80 percent of people who have the condition. Of those, as many as 20 percent have moderate to severe chronic plaque psoriasis. A need for additional therapies remains. According to recently published surveys, approximately 50 per cent of patients with psoriasis are dissatisfied with their treatment. Under-treatment also represents a significant problem. Even though guidelines typically state that patients with moderate to severe psoriasis are candidates for systemic therapy, many treated adult plaque psoriasis patients appear to be undertreated, with approximately 30 per cent of treated moderate patients and 22 per cent of treated severe patients receiving only topical therapy in the United States.
Xeljanz is a prescription medicine called a Janus kinase (JAK) inhibitor. Xeljanz is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. It is not known if Xeljanz is safe and effective in people with Hepatitis B or C. Xeljanz is not for people with severe liver problems. It is not known if Xeljanz is safe and effective in children.