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AbbVie Seeks EU Nod for Subcutaneous Skyrizi in Crohn's Disease
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Key Takeaways
AbbVie filed with the EMA for subcutaneous Skyrizi induction in adult Crohn's disease patients.
Skyrizi's potential EU nod would add SC induction to the existing IV option, then SC dosing every eight weeks.
The filing is based on phase III AFFIRM data, in CD patients with/without prior advanced therapy failure.
AbbVie (ABBV - Free Report) announced that it has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for its blockbuster immunology drug, Skyrizi (risankizumab), for subcutaneous (SC) induction in adult patients with moderately to severely active Crohn's disease (CD).
If approved, adult patients with CD in the EU would have an additional SC induction option of Skyrizi alongside the currently approved intravenous (IV) induction regimen, followed by SC maintenance dosing every eight weeks.
The latest filing in the EU was based on data from the phase III AFFIRM study, which evaluated the safety and efficacy of Skyrizi SC as an induction treatment in adult patients with moderately to severely active CD, including patients with and without prior advanced therapy failure.
AbbVie is currently awaiting a U.S. regulatory decision on a SC induction regimen for Skyrizi in CD, expected in the fall. If approved, the regimen is expected to improve convenience and competitive positioning of Skyrizi while driving sales higher.
ABBV’s Price Performance
Year to date, shares of AbbVie have risen 15.6% compared with the industry’s rally of 18%.
Image Source: Zacks Investment Research
Skyrizi – a Key Top-Line Driver for AbbVie
Skyrizi is currently approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, both in the United States and in Europe. The drug remains a key growth driver for AbbVie.
Skyrizi sales increased 26.3% year over year on an operational basis to nearly $10 billion in the first six months of 2026, accounting for nearly 31% of the company’s total revenues. The drug is seeing strong performance across all its approved indications, especially in the popular inflammatory bowel disease (IBD) space, which includes two conditions — CD and ulcerative colitis (UC).
AbbVie is also evaluating Skyrizi-based combination regimens with assets like ABBV-382 (anti-α4β7) and ABBV-701 (anti-TL1A) to create best-in-class, durable remission therapies in IBD.
Notably, AbbVie expects a low single-digit pricing headwind for Skyrizi in 2026 and over the next few years. Moreover, the launch of J&J’s (JNJ - Free Report) new oral pill for treating moderate-to-severe plaque psoriasis, Icotyde, has increased competitive pressure for Skyrizi, which can impact the product’s prescription trends.
However, AbbVie, on its second-quarter 2026 conference call, said that it has not seen any material change in Skyrizi’s momentum since the launch of Icotyde by J&J and seems confident that it can navigate competition from the JNJ drug.
Competition is also intensifying in IBD. Eli Lilly (LLY - Free Report) has expanded its immunology presence following the FDA approval of Omvoh for treating UC in 2023. The expansion of Eli Lilly’s IBD portfolio adds another established player to an increasingly competitive market. The LLY drug is also approved for the CD indication.
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AbbVie Seeks EU Nod for Subcutaneous Skyrizi in Crohn's Disease
Key Takeaways
AbbVie (ABBV - Free Report) announced that it has submitted a regulatory application to the European Medicines Agency (EMA) seeking approval for its blockbuster immunology drug, Skyrizi (risankizumab), for subcutaneous (SC) induction in adult patients with moderately to severely active Crohn's disease (CD).
If approved, adult patients with CD in the EU would have an additional SC induction option of Skyrizi alongside the currently approved intravenous (IV) induction regimen, followed by SC maintenance dosing every eight weeks.
The latest filing in the EU was based on data from the phase III AFFIRM study, which evaluated the safety and efficacy of Skyrizi SC as an induction treatment in adult patients with moderately to severely active CD, including patients with and without prior advanced therapy failure.
AbbVie is currently awaiting a U.S. regulatory decision on a SC induction regimen for Skyrizi in CD, expected in the fall. If approved, the regimen is expected to improve convenience and competitive positioning of Skyrizi while driving sales higher.
ABBV’s Price Performance
Year to date, shares of AbbVie have risen 15.6% compared with the industry’s rally of 18%.
Image Source: Zacks Investment Research
Skyrizi – a Key Top-Line Driver for AbbVie
Skyrizi is currently approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis, both in the United States and in Europe. The drug remains a key growth driver for AbbVie.
Skyrizi sales increased 26.3% year over year on an operational basis to nearly $10 billion in the first six months of 2026, accounting for nearly 31% of the company’s total revenues. The drug is seeing strong performance across all its approved indications, especially in the popular inflammatory bowel disease (IBD) space, which includes two conditions — CD and ulcerative colitis (UC).
AbbVie is also evaluating Skyrizi-based combination regimens with assets like ABBV-382 (anti-α4β7) and ABBV-701 (anti-TL1A) to create best-in-class, durable remission therapies in IBD.
Notably, AbbVie expects a low single-digit pricing headwind for Skyrizi in 2026 and over the next few years. Moreover, the launch of J&J’s (JNJ - Free Report) new oral pill for treating moderate-to-severe plaque psoriasis, Icotyde, has increased competitive pressure for Skyrizi, which can impact the product’s prescription trends.
However, AbbVie, on its second-quarter 2026 conference call, said that it has not seen any material change in Skyrizi’s momentum since the launch of Icotyde by J&J and seems confident that it can navigate competition from the JNJ drug.
Competition is also intensifying in IBD. Eli Lilly (LLY - Free Report) has expanded its immunology presence following the FDA approval of Omvoh for treating UC in 2023. The expansion of Eli Lilly’s IBD portfolio adds another established player to an increasingly competitive market. The LLY drug is also approved for the CD indication.
ABBV's Zacks Rank
AbbVie currently has a Zacks Rank #3 (Hold).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.