Pfizer Announces FDA Accepts Supplemental New Drug Application for XELJANZ® (tofacitinib citrate) for the Treatment of Adult Patients with Moderately to Severely Active Ulcerative Colitis

NEW YORK, NY, USA I July 13, 2017 I Pfizer Inc. announced today that the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis (UC), has been accepted for filing by the U.S. Food and Drug Administration (FDA).

The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in March 2018 for the sNDA.

“Ulcerative colitis is a debilitating inflammatory disease that impacts the physical, emotional and social well-being of nearly one million people in the United States, many of whom are not able to manage their disease,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development, Pfizer Inc. “We look forward to working with the FDA as they consider the application for tofacitinib in UC, with the goal of offering, if approved, the first oral Janus kinase (JAK) inhibitor as a therapeutic option for people living with moderately to severely active UC.”

The sNDA submission package included data from three pivotal Phase 3 studies from the Oral Clinical Trials for tofAcitinib in ulceratiVE colitis global clinical development program (OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain) evaluating the safety and efficacy of tofacitinib in patients with moderately to severely active UC, and OCTAVE Open, the open label long-term extension study of tofacitinib in patients who completed or who had treatment failure in OCTAVE Sustain, or who were non-responders in OCTAVE Induction 1 or 2. Full results from OCTAVE Induction 1, OCTAVE Induction 2 and OCTAVE Sustain were published in The New England Journal of Medicine in May 2017.

About Ulcerative Colitis

UC is a chronic, debilitating and often misunderstood inflammatory bowel disease that affects millions of people worldwide. Symptoms of UC can include chronic diarrhea with blood and mucus, abdominal pain and cramping, fever and weight loss. While the exact cause of UC is unknown, it is believed to be the result of complex interactions between multiple factors that include genetic predisposition and an exaggerated immune response to a microbial trigger. UC can have a significant effect on work, family and social activities. Despite receiving treatment, half of patients continue to experience symptoms. Under these circumstances, surgery to remove the colon (colectomy), may be considered for some patients.

About Tofacitinib Citrate

Tofacitinib citrate is a Janus kinase (JAK) inhibitor. It is not currently approved for the treatment of UC.

As the developer of tofacitinib, Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of tofacitinib through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.

XELJANZ/XELJANZ XR U.S. Label Information

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

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

Pfizer Inc.: Working together for a healthier world®

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com.

SOURCE: Pfizer

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