A Supplemental Biologics License Application (sBLA) was recently submitted to the FDA seeking approval for ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of adolescents, aged 12 to 17 years, with moderate to severe plaque psoriasis. Ustekinumab has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
Recent research evaluated the safety and efficacy of ustekinumab in the treatment of adolescents with psoriasis. The results of the trial were consistent with the profile of the anti-IL-12/23 monoclonal antibody that has previously been observed in adult patients who received ustekinumab, according to the company.
“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, MD, 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 [ustekinumab] to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis."
A Supplemental Biologics License Application (sBLA) was recently submitted to the FDA seeking approval for ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of adolescents, aged 12 to 17 years, with moderate to severe plaque psoriasis. Ustekinumab has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
Recent research evaluated the safety and efficacy of ustekinumab in the treatment of adolescents with psoriasis. The results of the trial were consistent with the profile of the anti-IL-12/23 monoclonal antibody that has previously been observed in adult patients who received ustekinumab, according to the company.
“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, MD, 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 [ustekinumab] to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis."
A Supplemental Biologics License Application (sBLA) was recently submitted to the FDA seeking approval for ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of adolescents, aged 12 to 17 years, with moderate to severe plaque psoriasis. Ustekinumab has been approved in the United States for the treatment of adults with moderate to severe plaque psoriasis since September 2009.
Recent research evaluated the safety and efficacy of ustekinumab in the treatment of adolescents with psoriasis. The results of the trial were consistent with the profile of the anti-IL-12/23 monoclonal antibody that has previously been observed in adult patients who received ustekinumab, according to the company.
“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, MD, 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 [ustekinumab] to dermatologists and their adolescent patients as a new treatment option for moderate to severe plaque psoriasis."
