FDA clears at-home Skyrizi induction for Crohn’s disease

AbbVie ($ABBV) received FDA approval for subcutaneous induction dosing of Skyrizi in adults with moderately to severely active Crohn’s disease. Patients can now begin treatment at home using an on-body injector, extending that delivery option beyond maintenance therapy. The approved induction schedule is 720 milligrams at weeks zero, two, four and eight; maintenance begins at week 12 and continues every eight weeks.

The expanded administration option could make treatment initiation more convenient by reducing reliance on infusion appointments. In the supporting AFFIRM trial, 56% of Skyrizi recipients achieved clinical remission at week 12, versus 30% with placebo; endoscopic response rates were 43% and 15%. AbbVie reported no new safety risks. Intravenous induction remains an available alternative, and the announcement does not quantify additional sales from the change.

Sources:

• PR Newswire
• news.abbvie.com