NEW YORK, NY, USA I May 3, 2017 I Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also accepted for XELJANZ XR® (tofacitinib citrate) extended release 11 mg once daily use in PsA. The sNDA submission is based on data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program, which consisted of two pivotal trials and a long-term extension study, evaluating the safety and efficacy of XELJANZ in patients with active PsA who had failed prior PsA treatments. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in December 2017 for the sNDAs.
“Psoriatic arthritis is a complex disease involving joint inflammation and damage, psoriasis, and musculoskeletal inflammation, which may limit physical functioning for people living with the disease. Despite advances in the treatment of psoriatic arthritis in recent years, many people are still living with active disease and are in need of additional therapeutic options,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “We believe that XELJANZ has the potential to provide patients with psoriatic arthritis and their physicians a new treatment option that also offers oral administration. If approved, XELJANZ or once-daily XELJANZ XR would be the first and only Janus kinase inhibitor for the treatment of this chronic inflammatory disease.”
Two pivotal Phase 3 studies were included in the submission package. OPAL Broaden was conducted in conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations. The study included an active control arm of adalimumab. However, the study was not designed for non-inferiority or superiority comparisons between adalimumab and XELJANZ. OPAL Beyond was conducted in TNFi-IR patients and was the first PsA study focused exclusively in this population. Both studies met their primary efficacy endpoints showing a statistically significant improvement with XELJANZ 5 mg and 10 mg BID compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score. In both studies adverse events were more frequent with XELJANZ 5 mg and 10 mg BID versus placebo. Overall safety findings were consistent with those observed in the broader rheumatology clinical development program for XELJANZ. Interim results from OPAL Balance, the long-term extension study of XELJANZ in patients with active PsA, were also included in the submission package.
About Psoriatic Arthritis
Psoriatic Arthritis (PsA) is a chronic inflammatory multisystem disease. PsA can cause joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage. There are an estimated three million people in the U.S. and Europe combined with active PsA. Real world disease prevalence may be even higher because it is often misdiagnosed or goes undiagnosed altogether.
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is not currently approved for the treatment of PsA.
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK innovation. The XELJANZ RA development program includes more than eight years of safety data from the long-term extension studies representing over 21,100 patient-years of drug exposure to date.
XELJANZ is approved in more than 80 countries around the world for the treatment of moderately to severely active rheumatoid arthritis (RA). In the United States, Argentina, and Macau, XELJANZ XR is the first once-daily oral JAK inhibitor approved for the treatment of moderately to severely active RA.
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in children.
Please click the direct link to the full prescribing information for XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Pfizer Inc.: 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 @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer
SOURCE: Pfizer
Post Views: 78
NEW YORK, NY, USA I May 3, 2017 I Pfizer Inc. announced today that the United States Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib citrate) 5 mg twice daily (BID) for the treatment of adult patients with active psoriatic arthritis (PsA). A separate sNDA was also accepted for XELJANZ XR® (tofacitinib citrate) extended release 11 mg once daily use in PsA. The sNDA submission is based on data from the Phase 3 Oral Psoriatic Arthritis TriaLs (OPAL) clinical development program, which consisted of two pivotal trials and a long-term extension study, evaluating the safety and efficacy of XELJANZ in patients with active PsA who had failed prior PsA treatments. The FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in December 2017 for the sNDAs.
“Psoriatic arthritis is a complex disease involving joint inflammation and damage, psoriasis, and musculoskeletal inflammation, which may limit physical functioning for people living with the disease. Despite advances in the treatment of psoriatic arthritis in recent years, many people are still living with active disease and are in need of additional therapeutic options,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Global Product Development. “We believe that XELJANZ has the potential to provide patients with psoriatic arthritis and their physicians a new treatment option that also offers oral administration. If approved, XELJANZ or once-daily XELJANZ XR would be the first and only Janus kinase inhibitor for the treatment of this chronic inflammatory disease.”
Two pivotal Phase 3 studies were included in the submission package. OPAL Broaden was conducted in conventional synthetic disease-modifying antirheumatic drug (csDMARD) inadequate response (IR) and tumor necrosis factor inhibitor (TNFi)-naïve patient populations. The study included an active control arm of adalimumab. However, the study was not designed for non-inferiority or superiority comparisons between adalimumab and XELJANZ. OPAL Beyond was conducted in TNFi-IR patients and was the first PsA study focused exclusively in this population. Both studies met their primary efficacy endpoints showing a statistically significant improvement with XELJANZ 5 mg and 10 mg BID compared to treatment with placebo at three months as measured by American College of Rheumatology 20 (ACR20) response and change from baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) score. In both studies adverse events were more frequent with XELJANZ 5 mg and 10 mg BID versus placebo. Overall safety findings were consistent with those observed in the broader rheumatology clinical development program for XELJANZ. Interim results from OPAL Balance, the long-term extension study of XELJANZ in patients with active PsA, were also included in the submission package.
About Psoriatic Arthritis
Psoriatic Arthritis (PsA) is a chronic inflammatory multisystem disease. PsA can cause joint pain and stiffness, skin and nail psoriasis, swollen toes and fingers, persistent painful tendonitis, and irreversible joint damage. There are an estimated three million people in the U.S. and Europe combined with active PsA. Real world disease prevalence may be even higher because it is often misdiagnosed or goes undiagnosed altogether.
About XELJANZ (tofacitinib citrate) and XELJANZ XR (tofacitinib citrate) extended-release
XELJANZ®/XELJANZ XR® (tofacitinib citrate) is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ is not currently approved for the treatment of PsA.
As the developer of XELJANZ/XELJANZ XR, Pfizer is a leader in JAK innovation. The XELJANZ RA development program includes more than eight years of safety data from the long-term extension studies representing over 21,100 patient-years of drug exposure to date.
XELJANZ is approved in more than 80 countries around the world for the treatment of moderately to severely active rheumatoid arthritis (RA). In the United States, Argentina, and Macau, XELJANZ XR is the first once-daily oral JAK inhibitor approved for the treatment of moderately to severely active RA.
Pfizer is committed to advancing the science of JAK inhibition and enhancing understanding of XELJANZ through robust clinical development programs in the treatment of immune-mediated inflammatory conditions.
XELJANZ/XELJANZ XR U.S. Label Information
XELJANZ (tofacitinib citrate)/XELJANZ XR (tofacitinib citrate) extended-release is a prescription medicine called a Janus kinase (JAK) inhibitor. XELJANZ/XELJANZ XR is used to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. XELJANZ/XELJANZ XR may be used as a single agent or in combination with methotrexate (MTX) or other non-biologic disease-modifying antirheumatic drugs (DMARDs). Use of XELJANZ/XELJANZ XR in combination with biologic DMARDs or potent immunosuppressants, such as azathioprine and cyclosporine, is not recommended.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in people with hepatitis B or C.
- XELJANZ/XELJANZ XR is not for people with severe liver problems.
- It is not known if XELJANZ/XELJANZ XR is safe and effective in children.
Please click the direct link to the full prescribing information for XELJANZ/XELJANZ XR, including boxed warning and Medication Guide: http://labeling.pfizer.com/ShowLabeling.aspx?id=959.
Pfizer Inc.: 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 @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer
SOURCE: Pfizer
Post Views: 78
