XELJANZ/XELJANZ XR, the First Oral JAK Inhibitor in the U.S. for Adults with Moderate to Severe Rheumatoid Arthritis, is now Approved for Adults with Active Psoriatic Arthritis
NEW YORK, NY, USA I December 14, 2017 I Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA.
“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” said Angela Hwang, Global President, Inflammation and Immunology, Pfizer. “The approval of XELJANZ is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”
The recommended dose of XELJANZ/XELJANZ XR is in combination with nonbiologic DMARDs, and use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
The FDA approval of XELJANZ for the treatment of adult patients with active PsA was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, 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. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.
Both pivotal studies met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score at three months in patients receiving XELJANZ 5 mg BID treatment in combination with a nonbiologic DMARD, compared to those treated with placebo. In OPAL Broaden, 50% of patients taking XELJANZ 5 mg BID achieved an ACR20 response, compared to 33% of patients taking placebo (p≤0.05), at three months. In OPAL Beyond, 50% of patients achieved an ACR20 response with XELJANZ 5 mg BID, compared to 24% of patients taking placebo (p≤0.05), at three months. In both studies, statistically significant improvements in ACR20 response was also seen with XELJANZ 5 mg BID compared to placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% and 6% [p=0.0003], respectively; OPAL Beyond: 27% and 13% [p=0.0046], respectively).
“As a practicing rheumatologist, I’ve seen the significant physical impact psoriatic arthritis has on people living with the disease, and many patients are looking for additional therapeutic options,” said Philip Mease, M.D., Swedish Medical Center, University of Washington and study investigator. “I’m pleased that XELJANZ is now available for use in the treatment of this chronic condition.”
The safety profile observed in patients with active psoriatic arthritis treated with XELJANZ was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events observed occurring in greater than 3% of patients on XELJANZ 5 mg BID were nasopharyngitis, upper respiratory tract infection, headache and diarrhea. Please see Important Safety Information below.
“Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “As an organization that advocates for people living with psoriatic arthritis, we welcome the availability of new therapies for treating this disease.”
About the OPAL Clinical Development Program
OPAL Broaden was a 12-month study in adult patients with active PsA who had an inadequate response to nonbiologic DMARDs and who were tumor necrosis factor inhibitor (TNFi) naïve. The study included an active control arm of adalimumab 40 mg administered subcutaneously every two weeks; however, the study was not powered for non-inferiority or superiority comparisons between tofacitinib and adalimumab. OPAL Beyond was a six-month study of adult patients with active PsA who had an inadequate response to a TNFi. All patients had active PsA for at least six months based upon the Classification Criteria for Psoriatic Arthritis (CASPAR), at least three tender/painful joints and at least three swollen joints, and active plaque psoriasis. In both studies, all patients were required to receive a stable background dose of a single nonbiologic DMARD.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments or skin. PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.
About XELJANZ/XELJANZ XR (tofacitinib)
XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for moderate to severe rheumatoid arthritis (RA) and is now approved for adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). As the developer of XELJANZ, 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.
Please see full Prescribing Information for XELJANZ/XELJANZ XR available at: http://labeling.pfizer.com/showlabeling.aspx?id=959
INDICATIONS
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.
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
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XELJANZ/XELJANZ XR, the First Oral JAK Inhibitor in the U.S. for Adults with Moderate to Severe Rheumatoid Arthritis, is now Approved for Adults with Active Psoriatic Arthritis
NEW YORK, NY, USA I December 14, 2017 I Pfizer Inc. (NYSE:PFE) announced today that the United States Food and Drug Administration (FDA) has approved XELJANZ® 5 mg twice daily (BID) and XELJANZ® XR (tofacitinib) extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for both moderate to severe rheumatoid arthritis (RA) and active PsA.
“Psoriatic arthritis is a complex and progressive disease with an unpredictable course,” said Angela Hwang, Global President, Inflammation and Immunology, Pfizer. “The approval of XELJANZ is an important step forward for patients seeking new treatments and is a testament to Pfizer’s unwavering commitment to advancing patient care.”
The recommended dose of XELJANZ/XELJANZ XR is in combination with nonbiologic DMARDs, and use in combination with biologic DMARDs or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
The FDA approval of XELJANZ for the treatment of adult patients with active PsA was based on data from the Phase 3 Oral Psoriatic Arthritis Trial (OPAL) clinical development program, 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. The findings from OPAL Broaden and OPAL Beyond were published in October 2017 in the New England Journal of Medicine.
Both pivotal studies met their two primary efficacy endpoints, demonstrating statistically significant improvements in American College of Rheumatology 20 (ACR20) response and change from baseline in the Health Assessment Questionnaire–Disability Index (HAQ-DI) score at three months in patients receiving XELJANZ 5 mg BID treatment in combination with a nonbiologic DMARD, compared to those treated with placebo. In OPAL Broaden, 50% of patients taking XELJANZ 5 mg BID achieved an ACR20 response, compared to 33% of patients taking placebo (p≤0.05), at three months. In OPAL Beyond, 50% of patients achieved an ACR20 response with XELJANZ 5 mg BID, compared to 24% of patients taking placebo (p≤0.05), at three months. In both studies, statistically significant improvements in ACR20 response was also seen with XELJANZ 5 mg BID compared to placebo at week 2, a secondary endpoint and the first post-baseline assessment (OPAL Broaden: 22% and 6% [p=0.0003], respectively; OPAL Beyond: 27% and 13% [p=0.0046], respectively).
“As a practicing rheumatologist, I’ve seen the significant physical impact psoriatic arthritis has on people living with the disease, and many patients are looking for additional therapeutic options,” said Philip Mease, M.D., Swedish Medical Center, University of Washington and study investigator. “I’m pleased that XELJANZ is now available for use in the treatment of this chronic condition.”
The safety profile observed in patients with active psoriatic arthritis treated with XELJANZ was consistent with the safety profile observed in rheumatoid arthritis patients. The most common adverse events observed occurring in greater than 3% of patients on XELJANZ 5 mg BID were nasopharyngitis, upper respiratory tract infection, headache and diarrhea. Please see Important Safety Information below.
“Psoriatic arthritis is a serious and debilitating chronic illness that should be diagnosed and treated early,” said Randy Beranek, president and CEO, National Psoriasis Foundation. “As an organization that advocates for people living with psoriatic arthritis, we welcome the availability of new therapies for treating this disease.”
About the OPAL Clinical Development Program
OPAL Broaden was a 12-month study in adult patients with active PsA who had an inadequate response to nonbiologic DMARDs and who were tumor necrosis factor inhibitor (TNFi) naïve. The study included an active control arm of adalimumab 40 mg administered subcutaneously every two weeks; however, the study was not powered for non-inferiority or superiority comparisons between tofacitinib and adalimumab. OPAL Beyond was a six-month study of adult patients with active PsA who had an inadequate response to a TNFi. All patients had active PsA for at least six months based upon the Classification Criteria for Psoriatic Arthritis (CASPAR), at least three tender/painful joints and at least three swollen joints, and active plaque psoriasis. In both studies, all patients were required to receive a stable background dose of a single nonbiologic DMARD.
About Psoriatic Arthritis
Psoriatic arthritis (PsA) is a chronic, autoimmune, inflammatory disease that may include manifestations in peripheral joints, tendons, ligaments or skin. PsA may include a variety of symptoms such as joint pain and stiffness, swollen toes and/or fingers and reduced range of motion.
About XELJANZ/XELJANZ XR (tofacitinib)
XELJANZ/XELJANZ XR is the first and only Janus kinase (JAK) inhibitor approved by the FDA for moderate to severe rheumatoid arthritis (RA) and is now approved for adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). As the developer of XELJANZ, 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.
Please see full Prescribing Information for XELJANZ/XELJANZ XR available at: http://labeling.pfizer.com/showlabeling.aspx?id=959
INDICATIONS
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.
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: 590
