FDA approves subcutaneous SKYRIZI induction regimen for Crohn’s disease

AbbVie has received U.S. Food and Drug Administration approval for a subcutaneous induction regimen of SKYRIZI, also known as risankizumab-rzaa, for adults with moderately to severely active Crohn’s disease.

The approval gives patients the option to begin treatment at home using an on-body injector rather than starting therapy through an intravenous induction regimen.

Patients can then continue maintenance treatment with the same on-body injector once every eight weeks.

The FDA decision was supported by findings from the Phase III AFFIRM study, which evaluated subcutaneous SKYRIZI against placebo in patients with moderately to severely active Crohn’s disease.

The trial met both co-primary endpoints at week 12, demonstrating significantly higher rates of clinical remission and endoscopic response with SKYRIZI.

Results were particularly strong among patients who had not previously experienced failure with an advanced therapy.

In this advanced therapy-naïve group, 74% of patients receiving subcutaneous SKYRIZI achieved clinical remission at week 12 compared with 27% of those receiving placebo.

Endoscopic response was achieved by 60% of advanced therapy-naïve patients receiving SKYRIZI compared with 15% in the placebo group.

Subcutaneous SKYRIZI also demonstrated higher efficacy than placebo among patients who had previously failed advanced therapies.

The study also met secondary endpoints, including endoscopic remission and improvements in FACIT fatigue scores at week 12.

Roopal Thakkar, MD, Executive Vice President of Research and Development and Chief Scientific Officer at AbbVie, said the approval provides patients and physicians with greater flexibility in how treatment with SKYRIZI is initiated.

He said the new administration option builds on the established efficacy of SKYRIZI while allowing treatment to begin outside an infusion setting.

The safety profile of subcutaneous induction was generally consistent with the established safety profile of SKYRIZI in Crohn’s disease.

No new safety risks were identified in the AFFIRM study.

The FDA also approved an update to the U.S. prescribing information for SKYRIZI across all indications.

The revised warning and precautions section allows healthcare professionals to use clinical judgement when deciding whether tuberculosis testing is required before treatment.

The latest approval expands the administration options available for SKYRIZI in Crohn’s disease and allows patients to use an on-body injector during both induction and maintenance treatment.

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Related Topics and Keywords

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