CNTO 1959 (guselkumab) filed with EMA for moderate to severe plaque psoriasis- Janssen
Janssen-Cilag announced the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking approval of CNTO 1959 (guselkumab) for the treatment of adults living with moderate to severe plaque psoriasis. 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.
These studies are VOYAGE 1, VOYAGE 2 and NAVIGATE Phase III studies, and the X-PLORE Phase II study, which appeared in The New England Journal of Medicine in July 2015.
Comment: 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.
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