Pfizer Receives EC Approval for XELJANZ

Pfizer Inc. (PFE) has bagged the European Commission’s (EC) approval for the first-of-its-kind oral Janus kinase (JAK) inhibitor XELJANZ (tofacitinib) to be dosed 5 mg twice daily for the treatment of adults with active ankylosing spondylitis (AS). These patients include individuals who have had an inadequate response to conventional therapy.

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The regulator’s approval followed the data from a Phase 3 study, which evaluated the efficacy and safety of tofacitinib versus placebo in 269 adult patients living with active AS. Markedly, the study met its primary endpoint.

The inhibitor has been approved for five indications in the European Union (EU), which include adults with moderate to severe active rheumatoid arthritis (RA), adults with 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) and juvenile psoriatic arthritis (PsA).

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.

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Official Comments

International Developed Markets Regional President of Inflammation & Immunology at Pfizer, Ana Paula Carvalho, said, “Ankylosing spondylitis is a debilitating and chronic immuno-inflammatory disease that affects the lives of more than one million people in the EU who are in need of additional treatment options. We are proud to make XELJANZ, a medicine that does not require an injection or an infusion, available to patients and their healthcare providers to help address this unmet medical need.” (See Pfizer stock charts on TipRanks)

Analysts Recommendation

On November 18, a BMO Capital analyst initiated coverage on the stock with a Buy rating and a price target of $60 (16.71% upside potential).

The rest of the Street is cautiously optimistic about the stock and has a Moderate Buy consensus rating based on 4 Buys and 9 Holds. The average Pfizer price target of $47.67 implies 7.27% downside potential from current levels. Shares have increased 42.1% over the past year.

Risk Analysis

According to the new TipRanks’ Risk Factors tool, the 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.