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Janssen seeks EMA approval of guselkumab for treating psoriasis

Janssen-Cilag International NV announced it has submitted a marketing authorization application to the European Medicines Agency for the approval of guselkumab to treat adults with moderate-to-severe plaque psoriasis.

Data from four studies evaluating the safety and efficacy of guselkumab, a human monoclonal antibody that targets interleukin-23 when administered by subcutaneous injection in treating adults with moderate to severe plaque psoriasis, were used in the submission, according to a press release.

Results from VOYAGE 1, one of three phase 3 studies, were recently presented at the European Academy of Dermatology and Venereology congress.

“We look forward to working with the [European Medicines Agency (EMA)] during the agency’s review of the application as we seek approval of guselkumab in the treatment of adults living with moderate to severe plaque psoriasis in the European Union,” Newman Yeilding, MD, head of immunology development, Janssen Research & Development LLC, stated in the release.

Janssen Biotech announced on Nov. 17 the submission of a biologics license application of the FDA seeking approval of gulselkumab for treating adults with moderate-to-severe plaque psoriasis, according to the release.

Reference: www.janssen.com