FDA Rejects Expanded Approval of Pfizer’s Arthritis Drug Xeljanz

Pfizer Receives Complete Response Letter from FDA for Oral XELJANZ® (tofacitinib citrate) Supplemental New Drug Application for Moderate to Severe Chronic Plaque Psoriasis
Pfizer Inc. (NYSE: PFE) announced today it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) for the treatment of adult patients with moderate to severe chronic plaque psoriasis. The Agency provided recommendations specific to the moderate to severe chronic plaque psoriasis sNDA. Pfizer will work with the Agency to determine an appropriate path forward to address their comments, including providing additional safety analyses of XELJANZ for the proposed indication.

“Pfizer remains committed to XELJANZ based on the strength of the clinical data for the treatment of psoriasis,” said Kenneth Verburg, PhD, senior vice president and head of global medicines development, Global Innovative Pharma Business. “It is our goal to work closely with the FDA to understand and address their comments about our filing for the use of XELJANZ in patients with chronic plaque psoriasis.”

Psoriasis affects 7.4 million people in the United States.1 The most common form is plaque psoriasis, which affects about 80 percent of people who have the condition.2a Of those, as many as 20 percent have moderate to severe chronic plaque psoriasis.2b

About XELJANZ

XELJANZ (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) Inhibitor.

XELJANZ is the first and only JAK inhibitor approved in over 40 countries around the world for the treatment of moderate to severe rheumatoid arthritis (RA) as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs (DMARDs). The clinical profile of XELJANZ in RA has been studied in approximately 6,200 patients with approximately 16,800 patient-years of drug exposure in the global clinical development program for XELJANZ in moderate to severe RA.

Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through a robust clinical development program in a range of immune-mediated inflammatory conditions in the areas of rheumatology, dermatology and gastroenterology.

XELJANZ U.S. Label Information

XELJANZ is a prescription medicine called a Janus kinase (JAK) inhibitor. The recommended dose is 5 mg twice-daily (BID). XELJANZ is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate (MTX) did not work well. XELJANZ may be used as a single agent or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine is not recommended.

• It is not known if XELJANZ is safe and effective in people with hepatitis B or C.
• XELJANZ is not for people with severe liver problems.
• It is not known if XELJANZ is safe and effective in children.

Important Safety Information

• XELJANZ can lower the ability of the immune system to fight infections. Some people have serious infections while taking XELJANZ, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Healthcare providers should test patients for TB before starting XELJANZ, and monitor them closely for signs and symptoms of TB and other infections during treatment. People should not start taking XELJANZ if they have any kind of infection unless their healthcare provider tells them it is okay.

  People may be at a higher risk of developing shingles.

• XELJANZ may increase the risk of certain cancers by changing the way the immune system works. Lymphoma and other cancers, including skin cancers, have happened in patients taking XELJANZ.
• The risks and benefits of treatment should be considered prior to initiating XELJANZ in patients with chronic or recurrent infection; who have been exposed to tuberculosis; with a history of a serious or an opportunistic infection; who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or with underlying conditions that may predispose them to infection.
• Viral reactivation, including cases of herpes virus reactivation (e.g., herpes zoster), was observed in clinical studies with XELJANZ.
• Use of live vaccines should be avoided concurrently with XELJANZ. Update immunizations in agreement with current immunization guidelines prior to initiating XELJANZ therapy.
• Some people who have taken XELJANZ with certain other medicines to prevent kidney transplant rejection have had a problem with certain white blood cells growing out of control (Epstein Barr virus-associated post-transplant lymphoproliferative disorder).
• Some people taking XELJANZ get tears in their stomach or intestines. This happens most often in people who also take nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or methotrexate. Patients should tell their healthcare provider right away if they have fever and stomach-area pain that does not go away, or a change in bowel habits. XELJANZ should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis).
• XELJANZ can cause changes in certain lab test results including low blood cell counts, increases in certain liver tests, and increases in cholesterol levels. Healthcare providers should do blood tests before starting patients on XELJANZ and while they are taking XELJANZ, to check for these side effects. Normal cholesterol levels are important to good heart health. Healthcare providers may stop XELJANZ treatment because of changes in blood cell counts or liver test results.
• Use of XELJANZ in patients with severe hepatic impairment is not recommended.
• Patients should tell their healthcare providers if they plan to become pregnant or are pregnant.

It is not known if XELJANZ will harm an unborn baby. To monitor the outcomes of pregnant women exposed to XELJANZ, a registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972.

• Patients should tell their healthcare providers if they plan to breastfeed or are breastfeeding. Patients and their healthcare provider should decide if they will take XELJANZ or breastfeed. They should not do both.

• In carriers of the hepatitis B or C virus (viruses that affect the liver), the virus may become active while using XELJANZ. Healthcare providers may do blood tests before and during treatment with XELJANZ.
• Common side effects include upper respiratory tract infections (common cold, sinus infections), headache, diarrhea, and nasal congestion, sore throat, and runny nose (nasopharyngitis).

Please click the direct link to the full prescribing information for XELJANZ, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.

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DISCLOSURE NOTICE: The information contained in this release is as of October 14, 2015. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments.

This release contains forward-looking information about XELJANZ, including its potential benefits and a potential indication for the treatment of adult patients with moderate to severe chronic plaque psoriasis that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the possibility of unfavorable clinical and non-clinical trial results, including unfavorable new data and additional analyses of existing data; uncertainties regarding the company’s ability to address the comments in the complete response letter to the satisfaction of the FDA; whether and when any applications for XELJANZ may be filed with regulatory authorities in any other jurisdictions; whether and when the FDA or regulatory authorities in other jurisdictions may approve the sNDA or other applications for the potential indication, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of XELJANZ; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the SEC and available at www.sec.gov and www.pfizer.com.