AbbVie presents applications to FDA and EMA for approval of SKYRIZI in psoriatic arthritis

AbbVie has submitted applications seeking approval for SKYRIZI (risankizumab-rzaa, 150 mg) and SKYRIZI (risankizumab, 150 mg) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), respectively, for the treatment of adults with active psoriatic arthritis.

Two pivotal Phase 3 studies – KEEPsAKE-1 and KEEPsAKE-2 – supported the submissions.

These studies evaluated SKYRIZI in adults suffering from active psoriatic arthritis, including those who had responded poorly or were intolerant to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

AbbVie vice-chairman and president Michael Severino said: “Most patients living with psoriatic arthritis experience both skin and joint disease which can be especially burdensome. Despite advancements, many patients cannot find relief from the signs and symptoms of this disease. We are dedicated to providing options that can help more patients living with psoriatic arthritis reach their treatment goals.”

In the Phase 3 KEEPsAKE-1 and KEEPsAKE-2 studies, SKYRIZI showed notable improvements in disease activity, skin clearance and physical function at week 24 versus placebo.

In both studies, at week 24 versus placebo, considerably more patients who were treated with SKYRIZI achieved the primary endpoint of ACR20 response.

The safety profile of SKYRIZI in both studies was largely consistent with the safety profile of SKYRIZI in plaque psoriasis. No further safety risks were observed.

SKYRIZI is an interleukin-23 (IL-23) inhibitor, which selectively blocks IL-23 by binding to its p19 subunit.

Psoriatic arthritis is a heterogeneous, systemic inflammatory disease with characteristic manifestations across multiple parts of the body including joints and skin.

SKYRIZI forms a portion of the collaboration between AbbVie and Boehringer Ingelheim. AbbVie leads global development and commercialisation of SKYRIZI.