FDA clears at-home subcutaneous starting regimen for AbbVie's Skyrizi in Crohn's

what happened

The US Food and Drug Administration has greenlit a subcutaneous induction option for Skyrizi (risankizumab-rzaa) in adults with moderately to severely active Crohn's disease, allowing patients to begin treatment at home using an on-body injector pack. The decision rests on data from the Phase 3 AFFIRM study, in which the subcutaneous form beat placebo on both co-primary goals: clinical remission and endoscopic response at Week 12.

Maintenance dosing continues with an on-body injector every eight weeks, and the intravenous induction route cleared earlier remains available. The agency also revised the prescribing information for all approved uses: doctors are now advised to weigh tuberculosis evaluation before starting therapy, based on clinical judgment, and mandatory TB testing is no longer required. According to TradingView, citing RTTNews, AbbVie shares (ABBV) finished Friday's regular session at $285.64, up $0.45, or 0.16%.

why it matters

For AbbVie, the change widens how Skyrizi can be given and may make starting therapy simpler for patients and prescribers. The news mainly matters for the company's stock rather than the broader market. The source contains no revenue figures or financial forecasts.

market impact

AbbVie (ABBV): wider dosing options for Skyrizi may support interest in the stock, with little spillover to the wider market

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