November 25 2016
Janssen-Cilag International NV has announced about the submission of a Marketing Authorization Application to the European Medicines Agency (EMA) that seeks approval of guselkumab for treating adults with moderate to severe plaque psoriasis. Guselkumab is a human monoclonal antibody targeting the protein interleukin (IL)-23, which plays an important role in developing immune-mediated inflammatory diseases. Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells. This is often characterized by raised, scaly, inflamed, red lesions, or plaques, that can cause itching, discomfort and pain. According to a recent estimate, 14 million people in Europe have psoriasis, which can range from mild to severe and disabling, and can often impair quality of life significantly.
Newman Yeilding, MD, Head of Immunology Development, Janssen Research & Development, LLC, said: “We are committed to the discovery and development of innovative therapies to address the continued unmet medical needs of people living with psoriasis. We look forward to working with the EMA during the agency’s review of the application as we seek approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis in the European Union.”Janssen Submits Application Seeking Approval of Anti-Interleukin-23 Monoclonal Antibody Guselkumab to EMA for Treating Moderate-to-Severe Plaque Psoriasis last edit: 2016-12-06T16:22:36+00:00 da