The US Food and Drug Administration (FDA) has accepted for review Pfizer’s supplemental New Drug Application (sNDA) for Xeljanz in psoriasis.
Pfizer recently announced that the agency will review the 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 tested for treating adult patients with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.
The FDA anticipates to make a decision on whether to approve the sNDA in October 2015.
The company’s submission to the US health regulators is based on data from the late-stage OPT Program. The Phase III program consisted of five studies, including an ongoing long-term extension study, and was designed to evaluate Xeljanz 5 mg and 10 mg twice-daily in patients with moderate-to-severe chronic plaque psoriasis. The OPT program has yielded one of the largest databases for potential psoriasis indication, with more than 3,600 adult psoriasis patients enrolled across 36 countries.
“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.”
Psoriasis is a chronic, immune-mediated inflammatory skin disease, affecting the skin and other parts of the body, such as nails. It affects approximately 2-3 percent of people worldwide and 7.4 million in the US. Plaque psoriasis is the most common form of the disease, affecting roughly 80 percent of psoriasis patients. A recent survey found that approximately 50 percent of psoriasis patients are dissatisfied with their treatment.
Xeljanz is a small molecule that targets the JAK pathway, a signaling pathway inside the cells, which is thought to play a role in chronic inflammatory responses. The drug is already approved in 37 countries for the treatment of moderate to severe rheumatoid arthritis (RA). According to the company, Xeljanz can lower the ability of the immune system to fight infections and some people taking the drug have serious infections, such as tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread through the body.
Source: Pfizer Inc.