FDA approves Pfizer’s XELJANZ to treat rheumatoid arthritis

Pfizer Inc. (NYSE: PFE) has received approval from the U.S. Food and Drug Administration (FDA) for 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 with 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 approved for RA in more than 10 years.

On November 6, at 6:00 P.M. ET, Pfizer will convene a panel, including Pfizer leadership and a prominent RA expert, to discuss the implications of having an additional treatment option for RA patients and rheumatologists. These panelists will be available for a Q&A session following opening remarks.

• Geno Germano, President and General Manager, Specialty Care and Oncology, Pfizer - Pfizer's business approach to RA drug development
• Yvonne Greenstreet, MD, Senior Vice President and Head of Medicines Development, Specialty Care Business Unit, Pfizer - XELJANZ data and clinical development program; a new approach to treating RA
• Mark Flanagan, Senior Principal Scientist, Pfizer - Research perspective on the development of XELJANZ
• Vibeke Strand, MD, Adjunct Clinical Professor, Division of Immunology and Rheumatology, Stanford University School of Medicine - Clinical perspective on XELJANZ and what this new treatment option means for patients
• Liz Barrett, President, North America, Specialty Care Business Unit, Pfizer - Commitment to patients, details on patient access program