Xeljanz (tofacitinib citrate) filed at FDA for Plaque Psoriasis treatment-Pfizer

Pfizer Inc.announced that the FDA has accepted for review the 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 III Oral treatment Psoriasis Trials (OPT) Program, a global, multi-study, comprehensive clinical development program 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. 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.

Comment: Xeljanz's oral delivery method is an advantage over its injectable competitors, the anti-TNF agents Enbrel (etanercept) and Humira (adalimumab). Safety risks posed by the anti TNF drugs limits their use to severe cases. That is where companies like Celgene with oral anti-inflammatory Otezla (apremilast) and Pfizer with Xeljanz see an opportunity. Other competitors are Johnson & Johnson's Stelara (ustekinumab) which has shown superiority over Enbrel and newer products such as Novartis's anti-IL17 product Cosentyx (secukinumab) which has recently secured EU and US approvals for psoriasis. There are also biosimilar versions of Enbrel and Humira in the wings, including Remsima which has EU approval.