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Pfizer's (PFE) Xeljanz Gets FDA Approval for 4th Indication

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Pfizer (PFE - Free Report) announced that the FDA granted approval to its blockbuster drug, Xeljanz for its fourth indication. The latest approval is for the treatment of children and adolescents 2 years and older with active polyarticular course juvenile idiopathic arthritis (pcJIA), a chronic inflammatory disease 

The drug was approved for the indication in two formulations, a tablet (5 mg) and oral solution. While the tablet will be available immediately, the oral solution will be launched in the first quarter of next year.

Pfizer’s stock has declined 7.1% this year so far compared with a decrease of 1% for the industry.



Xeljanz, a JAK inhibitor, is presently approved to treat rheumatoid arthritis (RA), psoriatic arthritis and ulcerative colitis. Xeljanz is also being evaluated in late-stage studies for ankylosing spondylitis (AS) with top-line data expected to be presented this year.

Xeljanz is key revenue driver for Pfizer, recording sales of $1.09 billion in the first half of 2020, representing growth of 5% year over year. The approval for pcJIA has expanded the drug’s eligible patient population, which should drive sales higher in the future quarters.

JAK inhibitors are gradually becoming a key treatment option for RA, eczema and other inflammatory diseases. These medicines work by blocking a particular signal of a body’s immune response, cytokines, instead of suppressing the immune system as done by disease-modifying antirheumatic drugs. Other JAK inhibitors approved for different autoimmune or inflammatory diseases are Incyte’s (INCY - Free Report) Jakafi, Eli Lilly’s (LLY - Free Report) Olumiant and AbbVie’s (ABBV - Free Report) Rinvoq (upadacitinib).

Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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