HORSHAM, PA, USA I December 16, 2016 I Janssen Biotech, Inc. (Janssen) announced today the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA®, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
“Adolescence is an important developmental period, and a diagnosis of moderate to severe plaque psoriasis can present physical and emotional challenges for girls and boys,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “We look forward to collaborating with the FDA on this application with the hope that in the future, we may be able to offer STELARA® to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis.”
The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety of STELARA® in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Results from the CADMUS study have been previously published in the Journal of the American Academy of Dermatology in May 2015. The efficacy and safety profile of STELARA® in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving STELARA®.
About CADMUS
CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA® in pediatric patients 12 to 17 years of age with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed with psoriasis more than six months prior to first study agent administration and had a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician’s Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.
Patients were randomized 1:1:1 to receive subcutaneous injections of placebo, STELARA® standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA® half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA® dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA® SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children’s Dermatology Life Quality Index (CDLQI) [patient-reported outcome].
A Phase 3 study, CADMUS Jr, is currently ongoing to evaluate the efficacy and safety of STELARA® in the treatment of pediatric patients 6 to 11 years of age living with moderate to severe plaque psoriasis.
About STELARA® (ustekinumab)
STELARA® is a human interleukin (IL)-12 and IL-23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate; and moderately to severely active Crohn’s disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®, which is currently approved for the treatment of moderate to severe plaque psoriasis in 88 countries, active psoriatic arthritis in 75 countries, pediatric psoriasis in 38 countries and moderately to severely active Crohn’s disease in 32 countries.
About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, including 7.5 million Americans.1,3-7 The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world’s population is living with psoriasis.6
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at Twitter.com/JanssenGlobal.
Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
SOURCE: Janssen
Post Views: 23
HORSHAM, PA, USA I December 16, 2016 I Janssen Biotech, Inc. (Janssen) announced today the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of STELARA® (ustekinumab) for the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. It is estimated that 7.5 million Americans have psoriasis, which can range from mild to severe and disabling, and approximately one-third of those affected develop the immune-mediated disease before 20 years of age.2 STELARA®, a human monoclonal antibody that targets interleukin (IL)-12 and IL-23 cytokines, has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
“Adolescence is an important developmental period, and a diagnosis of moderate to severe plaque psoriasis can present physical and emotional challenges for girls and boys,” said Newman Yeilding, M.D., Head of Immunology Development, Janssen Research & Development, LLC. “We look forward to collaborating with the FDA on this application with the hope that in the future, we may be able to offer STELARA® to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis.”
The application is supported by data from the Phase 3 CADMUS registration study, which evaluated the efficacy and safety of STELARA® in the treatment of adolescents (12 to 17 years of age) with moderate to severe plaque psoriasis. Results from the CADMUS study have been previously published in the Journal of the American Academy of Dermatology in May 2015. The efficacy and safety profile of STELARA® in the CADMUS trial was consistent with the profile of this anti-IL-12/23 monoclonal antibody as previously observed in adult patients receiving STELARA®.
About CADMUS
CADMUS, a Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter trial, evaluated the efficacy and safety of STELARA® in pediatric patients 12 to 17 years of age with moderate to severe plaque psoriasis. Patients (N=110) had been diagnosed with psoriasis more than six months prior to first study agent administration and had a Psoriasis Area Severity Index (PASI) score greater than or equal to 12, a Physician’s Global Assessment (PGA) score greater than or equal to 3 and body surface area (BSA) involvement of at least 10 percent. In addition, patients were inadequately controlled with topical therapy or were candidates for systemic/phototherapy.
Patients were randomized 1:1:1 to receive subcutaneous injections of placebo, STELARA® standard dosing (SD) [intended to achieve exposures comparable to adults] or STELARA® half standard dosing (HSD) [intended to achieve exposures half of those seen in adults]. STELARA® dosing tiers were determined by body weight. Patients receiving placebo crossed over to receive STELARA® SD or HSD at weeks 12 and 16; all patients continued with maintenance dosing every 12 weeks through week 40. Final efficacy and safety evaluations were made at weeks 52 and 60, respectively. The primary endpoint of the study was a PGA score of cleared (0) or minimal (1) at week 12. Secondary endpoints at week 12 included at least a 75 or 90 percent improvement in psoriatic skin lesions, as measured by PASI 75 or PASI 90, and improvement in quality of life, as measured by the Children’s Dermatology Life Quality Index (CDLQI) [patient-reported outcome].
A Phase 3 study, CADMUS Jr, is currently ongoing to evaluate the efficacy and safety of STELARA® in the treatment of pediatric patients 6 to 11 years of age living with moderate to severe plaque psoriasis.
About STELARA® (ustekinumab)
STELARA® is a human interleukin (IL)-12 and IL-23 antagonist indicated in the U.S. for the treatment of adult patients with: moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis, alone or in combination with methotrexate; and moderately to severely active Crohn’s disease who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers.
The Janssen Pharmaceutical Companies of Johnson & Johnson maintain exclusive worldwide marketing rights to STELARA®, which is currently approved for the treatment of moderate to severe plaque psoriasis in 88 countries, active psoriatic arthritis in 75 countries, pediatric psoriasis in 38 countries and moderately to severely active Crohn’s disease in 32 countries.
About Psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterized by raised, inflamed, red lesions, or plaques, which can cause physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, including 7.5 million Americans.1,3-7 The disease symptoms can range from mild, to moderate, to severe and disabling. It is estimated that nearly three percent of the world’s population is living with psoriasis.6
About the Janssen Pharmaceutical Companies
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us at Twitter.com/JanssenGlobal.
Janssen Biotech, Inc. and Janssen Research & Development, LLC are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
SOURCE: Janssen
Post Views: 23
