AbbVie Announces Application of Skyrizi to FDA for Treatment of Crohn’s Disease

AbbVie has submitted an application to the FDA for the approval of Skyrizi (risankizumab-rzaa), a 600-mg intravenous induction and 360-mg subcutaneous maintenance therapy, for the treatment of individuals aged 16 years or older with moderate to severe Crohn’s disease, the company said in a statement.

“While there have been advancements in care, many people with Crohn's disease do not achieve lasting remission,” Tom Hudson, senior vice president of research and development and chief scientific officer of AbbVie, said in the statement. “This submission is an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often unpredictable disease.”

Two phase 3 trial studies, ADVANCE and MOTIVATE, show that a significantly greater proportion of individuals with Crohn’s disease who were treated with either dosage of the drug met their co-primary endpoints of clinical remission and endoscopic response at week 12 compared with the individuals receiving the placebo.

In a third trial, FORTIFY, results showed that a significantly greater proportion of individuals treated with either dosage achieve the co-primary endpoints of clinical remission and endoscopic response at 52 weeks compared with individuals treated with the placebo.

The safety profile for all 3 trials was consistent with the previous safety profile. Common symptoms include chills, cough, diarrhea, fever, muscle aches, shortness of breath, stomach pain, and sweating.

Results of the 3 phase 3 trials provided evidence of efficacy and safety.

Reference

AbbVie submits regulatory application to FDA for risankizumab-rzaa (SKYRIZI) for the treatment of patients 16 years or older with moderate to severe Crohn’s disease. AbbVie. News release. September 20, 2021. Accessed September 21, 2021. https://news.abbvie.com/news/press-releases/abbvie-submits-regulatory-application-to-fda-for-risankizumab-rzaa-skyrizi-for-treatment-patients-16-years-and-older-with-moderate-to-severe-crohns-disease.htm