NEW YORK, NY, USA I June 28, 2018 I Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.2
“People living with psoriatic arthritis may experience a variety of symptoms, making the condition particularly difficult to diagnose and treat,” said Angela Lukin, Regional President, Inflammation and Immunology, Pfizer. “We are proud that we are now able to offer XELJANZ as an option to adult patients living with active psoriatic arthritis in the European Union.”
The EC approval was based on a submission package that included data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program in PsA, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance.3,4,5
“Psoriatic arthritis, a chronic inflammatory condition which affects between 1.5 and 3 million people in Europe, causes joint pain and swelling that can eventually lead to permanent joint damage if not diagnosed and treated sufficiently early on,” said Frank Behrens, Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine & Pharmacology, Frankfurt, Germany. “This approval for XELJANZ is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition.”
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments or skin.6 PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.6,7,8
About XELJANZ® (tofacitinib citrate)
XELJANZ® (tofacitinib citrate) is the first and only Janus kinase (JAK) inhibitor approved by the FDA for three indications in adults: moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and moderately to severely active ulcerative colitis (UC). XELJANZ is now approved in more than 80 countries for the treatment of adult patients with moderate to severe RA, with additional applications pending globally for all three respective indications.
As the developer of XELJANZ, Pfizer is committed to advancing JAK science and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
INDICATIONS AND IMPORTANT XELJANZ® (tofaciitnib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Rheumatoid Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
- XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
- Limitations of Use: Use of XELJANZ in combination with biologic therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care 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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 17
NEW YORK, NY, USA I June 28, 2018 I Pfizer Inc. (NYSE:PFE) announced today that the European Commission (EC) has approved XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy.1 XELJANZ is the first and only oral Janus kinase (JAK) inhibitor to be approved in the European Union (EU) for the treatment of adults with active PsA. In 2017, XELJANZ in combination with MTX was approved in the EU for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more DMARDs.2
“People living with psoriatic arthritis may experience a variety of symptoms, making the condition particularly difficult to diagnose and treat,” said Angela Lukin, Regional President, Inflammation and Immunology, Pfizer. “We are proud that we are now able to offer XELJANZ as an option to adult patients living with active psoriatic arthritis in the European Union.”
The EC approval was based on a submission package that included data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program in PsA, which consisted of two pivotal studies, OPAL Broaden and OPAL Beyond, as well as available data from an ongoing long-term extension trial, OPAL Balance.3,4,5
“Psoriatic arthritis, a chronic inflammatory condition which affects between 1.5 and 3 million people in Europe, causes joint pain and swelling that can eventually lead to permanent joint damage if not diagnosed and treated sufficiently early on,” said Frank Behrens, Rheumatology at Goethe University and Fraunhofer IME-Translational Medicine & Pharmacology, Frankfurt, Germany. “This approval for XELJANZ is an important milestone for the psoriatic arthritis community, who are in need of an additional oral treatment option to help manage their condition.”
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments or skin.6 PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.6,7,8
About XELJANZ® (tofacitinib citrate)
XELJANZ® (tofacitinib citrate) is the first and only Janus kinase (JAK) inhibitor approved by the FDA for three indications in adults: moderately to severely active rheumatoid arthritis (RA), active psoriatic arthritis (PsA) and moderately to severely active ulcerative colitis (UC). XELJANZ is now approved in more than 80 countries for the treatment of adult patients with moderate to severe RA, with additional applications pending globally for all three respective indications.
As the developer of XELJANZ, Pfizer is committed to advancing JAK science and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
INDICATIONS AND IMPORTANT XELJANZ® (tofaciitnib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
Rheumatoid Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. It may be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Psoriatic Arthritis
- XELJANZ/XELJANZ XR (tofacitinib) is indicated for the treatment of adult patients with active psoriatic arthritis who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs).
- Limitations of Use: Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
Ulcerative Colitis
- XELJANZ (tofacitinib) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
- Limitations of Use: Use of XELJANZ in combination with biologic therapies for UC or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
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 health care products. Our global portfolio includes medicines and vaccines as well as many of the world’s best-known consumer health care 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, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.
SOURCE: Pfizer
Post Views: 17
