Pfizer’s Rheumatoid Arthritis Pill Approved by Food and Drug Administration (FDA) | Rheumatoid Arthritis Warrior

Pfizer’s Rheumatoid Arthritis Pill Approved by Food and Drug Administration (FDA)

Note: Click here to read more about Xeljanz, the first new oral medication for Rheumatoid Arthritis in 10 years, and a short list of questions and answers for patients. Sign up for regular blog updates by email to watch for more updates on this new treatment and others.

Pfizer press release about Xeljanz

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate. XELJANZ may be used as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs). XELJANZ should not be used in combination with biologic DMARDs or potent immunosuppressives, such as azathioprine and cyclosporine.

XELJANZ (ZEL’jans) is the first approved RA treatment in a new class of medicines known as Janus kinase (JAK) inhibitors and the first new oral DMARD for RA in more than 10 years. XELJANZ is approved as a second-line medicine for RA, which means treatment with a biologic is not required before taking XELJANZ.

“XELJANZ is an important new option that could potentially change the way rheumatologists treat this serious autoimmune disease,” said Ian Read, chairman and chief executive officer of Pfizer. “With its novel mechanism of action, the discovery and development of XELJANZ by Pfizer scientists reflects our commitment to R&D innovation and our dedication to bringing important and meaningful medicines to patients.”

XELJANZ is specifically designed to inhibit the JAK pathways, which are signaling pathways inside the cell that play an important role in the inflammation involved in RA. With one of the largest clinical databases of any RA drug ever submitted to the FDA for review, the comprehensive, multi-study, global clinical development program evaluated approximately 5,000 patients who represent a broad cross-section of the RA patient population.

“RA is a serious and disabling disease that affects people in their everyday lives, and many patients do not adequately respond or are intolerant to currently available therapies,” said study investigator Stanley Cohen, MD, clinical professor of rheumatology at the University of Texas Southwestern Medical School; co-director, Division of Rheumatology, Presbyterian Hospital Dallas; and co-medical director, Metroplex Clinical Research Center. “In clinical trials, XELJANZ significantly reduced the signs and symptoms of RA and improved physical function. As a physician, I am pleased that we have another choice for patients living with inadequately controlled, moderately to severely active RA.”

“In clinical trials, XELJANZ demonstrated consistent efficacy across a broad range of clinical measures and patient types, including patients who inadequately responded to non-biologic DMARDs and anti-TNF agents, and it has a safety profile that is well-characterized to date,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer. “We are proud of the comprehensive data that support the use of XELJANZ, and we are excited to make it available to patients in the U.S. as a powerful oral option that can be taken as a second-line treatment with or without methotrexate.”

Safety findings observed in the overall XELJANZ RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; decreased hemoglobin; liver enzyme elevations; and lipid elevations.

The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, diarrhea and nasopharyngitis.

Regarding the potential for further assessment by the FDA of the inhibition of structural damage, Pfizer plans to immediately discuss with the FDA the submission of the results of the previously disclosed ORAL Start (A3921069) study, which demonstrated significant efficacy of XELJANZ taken as monotherapy versus methotrexate, including inhibiting structural damage. The ORAL Start study was ongoing at the time of the New Drug Application submission and was not included in the original application to the FDA.

In the clinical trials, XELJANZ was studied in both a 5 mg and 10 mg twice-daily dosing regimen. The FDA has approved the 5 mg twice-daily dose in the second-line setting and has indicated that further data are required to assess the benefit: risk profile of the 10 mg twice-daily dose. Pfizer will continue to generate additional clinical data on the 10 mg twice-daily dose and work with the FDA to understand the additional data needed for further assessment of the 10 mg twice-daily dose.

FDA has approved XELJANZ with a Risk Evaluation and Mitigation Strategy (REMS) designed to inform healthcare providers and patients about the serious risks associated with XELJANZ treatment. The approved REMS includes a Medication Guide for patients, a communication plan for healthcare providers and pharmacists, and periodic submissions of assessments of the REMS. Pfizer has agreed to conduct post-marketing clinical trials to evaulate that long-term safety of XELJANZ and to assess XELJANZ in the pediatric population with polyarticular juvenile ideopathic arthritis (JIA).

For full prescribing information, including boxed warning and Medication Guide, please visit

xeljanz screenshot

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Kelly O'Neill

Kelly O'Neill (formerly Kelly Young) has worked about 12 years as an advocate helping patients to be better informed and have a greater voice in their healthcare. She is the author of the best-selling book Rheumatoid Arthritis Unmasked: 10 Dangers of Rheumatoid Disease. Kelly received national acknowledgement with the 2011 WebMD Health Hero award. She is the president of the Rheumatoid Patient Foundation. Through her writing and speaking, she builds a more accurate awareness of rheumatoid disease (RD) aka rheumatoid arthritis (RA) geared toward the public and medical community; creates ways to empower patients to advocate for improved diagnosis and treatment; and brings recognition and visibility to the RA patient journey. In addition to RA Warrior, she writes periodically for newsletters, magazines, and websites. There are over 60,000 connections of her highly interactive Facebook page. You can also connect with Kelly on Twitter or YouTube, or LinkedIn. She created the hashtag: #rheum. Kelly is a mother of five, longtime home-schooler, NASA enthusiast, and NFL fan. She has lived over fourteen years with unrelenting RD. See also https:/

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7 thoughts on “Pfizer’s Rheumatoid Arthritis Pill Approved by Food and Drug Administration (FDA)

  • November 7, 2012 at 4:33 am

    I am excited about this. This is really good news for patients to have an oral med as strong as the injections and infusions.

  • November 7, 2012 at 8:44 am

    I was filled with RA despair with having failed DMARDS ALL 3 ANTI TNF BIOLOGICS AND my last try with Remicade infusions doing nothing. Add my morning pity crying before I try to get out of bed and lo and behold I read your post in the new XELJANZ (Zeljanz)
    My CYTOKINE TNF AND IL 6 factors are both high. My SED IS NORMAL NOW SO I KNOW THERE IS MUCH MORE GOING ON in my body.
    Remicade was supposed to lower both and did not
    With this new oral pill supposedly attacking THE HUB OF THE INFLAMMATION MADE ME EXCITED to call my RA doctor first thing this morning to get a ‘script when available.
    Thank you RA WARRIOR for your website brought sunlight to my day! EXCUSE iPhone brevity I am away from my computer.

  • December 5, 2012 at 5:18 am

    I was on Remicade for 5 years and it was wonderful until it stopped working. I have had reactions to Orencia, Rituxan (that was an ER visit) and now they want to try Actemra. My doctor is the head of Rheumatology at a major University medical center and is on the fence with this drug and has yet to prescribe it until there is more data. I would love to hear if anyone has taken it and how it’s effected their RA and any side effects. Cost is a huge factor for me since I’m disabled on Medicare and I don’t qualify for the rebate programs and my husband and I make too much for any financial aid. More information from other patients would be very helpful. Thanks!

  • December 5, 2012 at 4:07 pm

    There is an even newer JAK inhibitor and it only supresses 1 of the 3 JAK’s. It is being made and just completed Phase 2 trials in Belgium. See GLPG0634.

    Gosh I hope these new drugs (hopefully specifically) for Rheumatoid come to Australia soon.

  • May 10, 2013 at 6:25 pm

    We have tried everything new that has become approved over the last fifteen-20 years. It works for about 6-12 months then fizzles out. Xeljanz for about 4 months so far has allowed the daily prendisone intake to go from 40 to 30 over about 2 months. We are going to keep trying to reduce but it does not seem probable yet. Goal is 20 per day. A little more pain meds are in order but the tradeoff seems favorable. My case is very severe but I’ve had it for 30 years(I’m 65) We’re hopeful again!

    • May 11, 2013 at 1:12 pm

      Good luck Bob. I hope it works for you. Thirty years is a long time.

  • May 11, 2013 at 2:15 pm

    Why aren’t doctors checking RA patients TNF and IL6 factors, – have had RA 25 tears now.

    Do not just check SED Etc. certain biologics are made to decrease cytokines but few vicims have these blood tests done. An example is MY TNF WAS NORMAL BUT MY INTERLEUKIN 6 was off the charts. My experienced RA doctor told me there were no tests. There are. I found them at Quest and it was found that Xeljanz dramatically dropped my il6.

    It was 54 prior to taking Xeljanz and normal range 3 – post Xeljanz!

    Others could be in the same boat. My god. I am so angry I’ve had – to for decades – be my own physician but in this course of having to wait my joints have been severely damaged. I am on my 5th month and my blood tests are all normal with this drug

    other bios help with TNF factors but some of us have a different problem. My TNF was normal. That’s why Humira helped for such a short time. SINCE XELJANZ is supposed to stop the inflammatory cytokines action at the hub, as it suggests, others should get a pre and post full cytokines blood panel done. PFIZER has 2 co pay programs because the drug is so expensive. If someone wants to email me I can give you tel numbers on where to begin Medicare does not pay either.
    You may think you are not eligible but you might be surprised because Pfizer wants this drug to be successful and obviously it is too expensive for the majority.
    There are 4 cytokines but INTERLEUKIN 6 and TUMOR NECROSIS FACTOR are the two common ones that RA drug studies are based upon


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