New oral XELJANZ TM, now available in Canada
KIRKLAND, QC, June 4, 2014 /CNW/ - Catherine Hofstetter was diagnosed with rheumatoid arthritis 22 years ago and it changed her life. "My diagnosis felt like a life sentence," says Hofstetter. "Even though I was able to find a treatment to help me manage my symptoms, small, everyday things like buttoning a shirt can still be difficult. New treatments are essential in bringing hope to patients that their disease can be managed."
Although multiple treatments for RA exist, there remains an unmet need for Canadians living with this serious autoimmune disease.1 Not everyone with RA responds to currently available treatments.2 But Canadians with RA now have a new oral treatment option with the approval of XELJANZ (tofacitinib citrate) by Health Canada.
"Up to one-third of people with RA are not adequately responding to current treatments and about half stop responding to a particular agent within five years," said Dr. William Bensen, Clinical Professor, McMaster University, Rheumatologist, St. Joseph's Hospital, Hamilton. "XELJANZ is a new oral option for Canadians living with this debilitating and chronic disease. Its mechanism of action targets the inflammation associated with rheumatoid arthritis from inside the cell."
XELJANZ: A NEW ORAL OPTION
XELJANZ is the first RA treatment in a new class of drugs known as Janus kinase (JAK) inhibitors, which are signaling pathways inside the cell that play an important role in the inflammation involved in this progressive disease.3
XELJANZ 5 mg twice daily in combination with methotrexate (MTX) is indicated for reducing the signs and symptoms of RA, in adult patients with moderately to severely active RA, who have had an inadequate response to MTX. In cases of intolerance to MTX, physicians may consider the use of XELJANZ alone.4
"Rheumatoid arthritis is a leading cause of disability in Canada.5 It brings with it a burden of pain that those living with the disease must face daily," said Joanne Simons, Chief Mission Officer, The Arthritis Society. "The availability of new medicines is a positive step forward for Canadians who suffer from rheumatoid arthritis."
The XELJANZ bottle cap has also been awarded The Arthritis Society's ease-of-use commendation, which recognizes the importance of helping make life easier for people who have arthritis and other physical limitations.
"Given Pfizer Canada's long heritage in the area of arthritis and rheumatology, we understand that the experiences and challenges for each person suffering from RA are unique," said Dr. Vratislav Hadrava, Chief Medical Officer, Pfizer Canada Inc. "The approval of XELJANZ gives Canadian physicians a new option to help address these challenges. We are also pleased that we can provide arthritis-friendly packaging for XELJANZ."
XELJANZ was originally discovered in Pfizer labs in Groton, Connecticut and over the course of 20 years Pfizer invested more than $1 billion into the discovery, development and commercialization of XELJANZ.
XELJANZ has been evaluated in approximately 4,800 patients yielding 7,000 patient-years of exposure in a comprehensive, global clinical development program that included five pivotal Phase 3 trials and two ongoing long-term extension studies in 45 countries. This large international clinical development program includes sites across Canada (including Quebec).
THE FACTS: RHEUMATOID ARTHRITIS IN CANADA5
- About one out of every 100 Canadians has rheumatoid arthritis (RA). That's approximately 300,000 Canadians.
- Anyone can get RA at any age, but it most often appears between the ages of 25 and 50.
- RA affects women three times more often than men.
- There remains an unmet medical need for additional therapeutic options with proven efficacy and acceptable safety profiles in patients with rheumatoid arthritis.
- RA can cause permanent joint damage quickly when it is not treated and controlled.
- Treating RA early and aggressively can improve the long-term outcome and significantly reduce damage.
ABOUT PFIZER CANADA INC.
Pfizer Canada Inc. is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. Historically, Pfizer Inc. has invested more than US$7 billion toward developing safe and effective medicines. At Pfizer, we're working together for a healthier world. To learn more about Pfizer Canada, visit pfizer.ca or you can follow us on Twitter (twitter.com/PfizerCA) or Facebook (facebook.com/Pfizer.Canada).
1 FDA Advisory Committee Briefing Document. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM302960.pdf. Last accessed May 21, 2014. (BD pg. 19)
2 Bykerk V. Unmet needs in rheumatoid arthritis. Journal of Rheumatology. 2009; 82; 42-46
3 Understanding Rheumatoid Arthritis and the JAK Pathways. Science Writers' Guide.
4 XELJANZ Product Monograph, Pfizer Canada Inc., April 2014
5 The Arthritis Society. Rheumatoid Arthritis. http://www.arthritis.ca/page.aspx?pid=982. Accessed May 22, 2014.
Image with caption: "The Facts: Rheumatoid Arthritis in Canada (CNW Group/Pfizer Canada Inc.)". Image available at: http://photos.newswire.ca/images/download/20140604_C8320_PHOTO_EN_41054.jpg
SOURCE: Pfizer Canada Inc.
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