Janssen has submitted a Type II Variation Application to the European Medicines Agency (EMA), seeking first-in class approval of its Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA).
If approved, it will mark the second approved indication for the human monoclonal antibody in the European Union.
Janssen, a division of Johnson & Johnson, says the submission is based on data from the Phase III DISCOVER-1 and DISCOVER-2 studies, a programme that comprises the first-ever Phase III studies evaluating a human monoclonal antibody targeting the p19 subunit of IL-23 in patients with active PsA.
Previous to this submission, the medicines was approved in the European Union for the treatment of adult patients with moderate to severe plaque psoriasis in November 2017, and has also been approved in the US, Canada, Japan and several other countries worldwide.
It’s estimated that up to a third of the 14 million people who are living with psoriasis in Europe will also develop PsA, a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.
Because of this, the submission the toe EMA is an “important milestone for people with psoriatic arthritis, who currently have limited treatment options that improve the signs and symptoms of the condition,” said Alyssa Johnsen, vice president, rheumatology disease area leader, Janssen.
She continued, “With this filing, we hope to offer clinicians a new and innovative treatment option for people living with psoriatic arthritis.”
Psoriatic arthritis is a chronic, immune-mediated inflammatory disease characterised by both joint inflammation and the skin lesions associated with psoriasis.