Janssen has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of guselkumab for the treatment of adults with plaque psoriasis.
Guselkumab is a human monoclonal antibody that targets the protein interleukin (IL)-23, which has been shown to play a key role in the development of immune-mediated inflammatory diseases, such is plaque psoriasis.
What is plaque psoriasis?
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching, discomfort and pain. It is estimated that 14 million Europeans have psoriasis, which can range from mild to severe and disabling, and can often significantly impair quality of life.
Speaking about tackling plaque psoriasis, 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.”
Results from 2 studies to be presented later
Data from four studies evaluating the efficacy and safety of guselkumab when administered by subcutaneous injection in the treatment of adults living with moderate to severe plaque psoriasis served as the basis for the submission: the VOYAGE 1 , VOYAGE 2 and Navigate 7 phase 3 studies, and the X-Pplore phase 2 study, which appeared in The New England Journal of Medicine in July 2015. Results from the Voyage 1 study were recently presented at the European Academy of Dermatology and Venereology (EADV) congress, and results from the Voyage 2 and Navigate studies are planned for presentation at upcoming scientific congresses.
Worldwide, 125 million people have psoriasis
Psoriasis is a chronic, autoimmune inflammatory disorder that results in the overproduction of skin cells, characterised by raised, inflamed, scaly, red lesions, or plaques, which can cause itching and physical pain. It is estimated that as many as 125 million people worldwide have psoriasis, including 14 million Europeans, and approximately 20% of people affected have cases that are considered moderate to severe.
Guselkumab is a human monoclonal antibody with a novel mechanism of action that targets the protein interleukin (IL)-23 and is in Phase 3 development as a subcutaneously administered therapy for the treatment of moderate to severe plaque psoriasis.
On November 17, Janssen Biotech announced the submission of a Biologics License Application to the USFDA seeking approval of guselkumab for the treatment of adults living with moderate to severe plaque psoriasis. Additionally, findings from a Phase 2 study evaluating guselkumab in the treatment of patients with active psoriatic arthritis were recently presented at the American College of Rheumatology meeting and a Phase 3 program for this indication is planned.