Pfizer Bags FDA Approval for XELJANZ

Pfizer, Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has given the green light to the supplemental New Drug Application (NDA) for the first-of-its-kind oral Janus kinase (JAK) inhibitor XELJANZ (tofacitinib).

XELJANZ is designed to treat adults with active ankylosing spondylitis (AS), a chronic, inflammatory disease that affects men and women in early adulthood. These patients include individuals who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Supporting Data

The regulator’s approval followed data from a Phase 3 study evaluating the efficacy and safety of tofacitinib 5 mg twice daily versus placebo in 269 adult patients living with active AS. Markedly, the study met its primary endpoints.

The inhibitor has been approved for five indications in the U.S., which include adults with moderate to severe active rheumatoid arthritis (RA), adults with active AS, active psoriatic arthritis (PsA), adults with moderately to severely active ulcerative colitis (UC), and patients 2 years of age or older with active polyarticular juvenile idiopathic arthritis (pcJIA).

Globally, XELJANZ has been studied in more than 50 clinical trials, including more than 20 trials in RA patients, and prescribed to over 300,000 adult patients since 2012.

Official Comments

Global President of Inflammation & Immunology at Pfizer, Mike Gladstone, said, “We are proud to offer XELJANZ, a treatment option for ankylosing spondylitis that does not require an injection or an infusion, to treat this debilitating and chronic immuno-inflammatory disease. This regulatory approval affirms the clinical value and versatility of XELJANZ, the first and only Janus kinase (JAK) inhibitor approved for five indications in the United States for the treatment of patients with certain immuno-inflammatory conditions.” (See Pfizer stock price charts)

Other Approvals

Last month, XELJANZ was approved by the European Commission (EC) for the treatment of adults with active AS for five indications in the European Union (EU).

Analyst Recommendations

Recently, J.P. Morgan analyst Chris Schott maintained a Hold rating and a price target of $53 (4.6% downside potential) on the stock.

The rest of the Street is cautiously optimistic about the stock, with a Moderate Buy consensus rating based on 7 Buys and 10 Holds. The average Pfizer price target of $54.47 implies 1.93% downside potential from current levels. Shares have increased 43.5% over the past year.

Risk Analysis

According to the new TipRanks Risk Factors tool, Pfizer stock is at risk mainly from three factors: Tech and Innovation, Ability to Sell, and Macro & Political, which contribute 25%, 25%, and 17%, respectively to the total 24 risks identified for the stock.