Pfizer Announces Data For Investigational Compound Tofacitinib In Rheumatoid Arthritis To Be Presented At The American College Of Rheumatology 2012 Annual Meeting
Pfizer Inc.Media: Victoria DavisO: 484-865-5194E: orInvestor: Jennifer DavisO: 212-733-0717E:
Pfizer Inc. (NYSE: PFE) announced today that 14 abstracts for tofacitinib, an investigational oral Janus kinase (JAK) inhibitor for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA), will be presented at the American College of Rheumatology (ACR) / Association of Rheumatology Health Professionals (ARHP) 2012 Annual Meeting, which is being held November 9-14 in Washington, D.C.
Tofacitinib is currently under review for the treatment of moderate–to-severe active RA by several regulatory agencies around the world, including in the United States, Europe and Japan. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) date of November 21, 2012. If approved, tofacitinib would be the first RA treatment in a new class of medicines known as JAK inhibitors and the first new oral disease-modifying antirheumatic drug (or DMARD) for RA in more than 10 years.
The overall safety profile of tofacitinib was consistent across all aforementioned trials. Notable safety findings observed in the tofacitinib RA program include serious and other important infections, including tuberculosis and herpes zoster; malignancies, including lymphoma; gastrointestinal perforations; decreased neutrophil and lymphocyte counts; and lipid elevations. The most common serious adverse events were serious infections. The most commonly reported adverse events were upper respiratory tract infections, headache, nasopharyngitis and diarrhea.
The following data will also be presented:
Additional Efficacy Data
Additional Safety Data
Rheumatoid arthritis is a chronic inflammatory autoimmune disease that typically affects the hands and feet, although any joint lined by a synovial membrane may be affected. RA affects approximately 1.6 million Americansand 23.7 million people worldwide. Although multiple treatments are available, many patients do not adequately respond. Specifically, up to one-third of patients do not adequately respond and about half stop responding to any particular DMARD within five years. There remains a need for additional options.
Tofacitinib is a novel, oral JAK inhibitor that is being investigated as a targeted immunomodulator and disease-modifying therapy for RA. Unlike recent therapies for RA, which are directed at extracellular targets such as pro-inflammatory cytokines, tofacitinib takes a novel approach targeting the intracellular pathways that operate as hubs in the inflammatory cytokine network.
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