Janssen seeks to expand Tremfya's EU label

23 October 2019

A Type II variation application has been submitted to the European Medicines Agency (EMA) seeking approval for Tremfya (guselkumab) to treat adults with active psoriatic arthritis (PsA).

If approved, it will be the second approved indication for Tremfya in the European Union (EU), and also the first selective IL-23 p19 subunit inhibitor for people in the EU with active PsA.

Alyssa Johnsen, vice president, rheumatology disease area leader, at Janssen Research & Development, which is part of the Johnson & Johnson (NYSE: JNJ) group, commented: “This submission to the EMA is an important milestone for people with PsA, who currently have limited treatment options that improve the signs and symptoms of the condition.

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