Janssen applies for EU approval of plaque psoriasis therapy

Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) for a new plaque psoriasis therapy.

The company is seeking approval of guselkumab, a human monoclonal antibody that targets the protein interleukin-23 (IL-23, for the treatment of adults patients with moderate to severe forms of the disease.

IL-23 has been shown to play a key role in the development of immune-mediated inflammatory diseases, making it an effective target for treatment.

This application is supported by data from three phase III studies and a phase II trial that demonstrated the efficacy and safety of guselkumab when administered by subcutaneous injection.

Dr Newman Yeilding, head of immunology development for Janssen's research and development division, said: "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 EU."

The company also filed a biologics licence application with the US Food and Drug Administration seeking approval of guselkumab in the same indication earlier this month.

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