AbbVie's (ABBV) Skyrizi Succeeds in Crohn's Maintenance Study
AbbVie ABBV announced that the phase III maintenance study — FORTIFY — evaluating its psoriasis drug, Skyrizi (risankizumab) as maintenance treatment in patients with moderate-to- severe Crohn’s disease met its co-primary endpoints of endoscopic response and clinical remission.
The FORTIFY study evaluated two doses — 180mg and 360mg — of subcutaneous (SC) Skyrizi in patients from previously completed late-studies — ADVANCE and MOTIVATE— who responded to risankizumab intravenous (IV) induction treatment of 12 weeks. Some patients who responded to Skyrizi IV treatment were stopped treatment with Skyrizi in the FORTIFY study. The FORTIFY study then evaluated the efficacy and safety of Skyrizi SC as maintenance treatment for a year compared to withdrawal from Skyrizi treatment.
Data from the FORTIFY study demonstrated that 360mg dose of Skyrizi SC achieved endoscopic response and clinical remission in significantly greater proportion of patients after 52 weeks of treatment compared to patients not receiving treatment with Skyrizi following the induction treatment of 12 weeks.
The FORTIFY study had two analysis plans for clinical remission — Crohn's Disease Activity Index (CDAI) for the U.S. analysis plan, and stool frequency and abdominal pain the outside of the U.S. analysis plan — due to regulatory requirements in the different regions. The 180mg dose of Skyrizi achieved statistical significance in endoscopic response as well as clinical remission per U.S. analysis plan but failed to achieve statistical significance for clinical remission per outside U.S. analysis plan.
Data from ADVANCE and MOTIVATE studies evaluating two doses of Skyrizi IV (600mg & 1200mg), announced in January 2021, had shown that significantly more patients treated with risankizumab achieved clinical remission and endoscopic response, co-primary endpoints of both studies, at week 12 versus placebo.
AbbVie plans to submit the FORTIFY study data along with data from ADVANCE and MOTIVATE studies to regulatory authorities for a potential label expansion of the drug in Crohn’s disease.
The company is also developing the drug in late-stage studies for psoriasis and psoriatic arthritis, and a phase II study is evaluating it in ulcerative colitis.
AbbVie’s stock has risen 4% so far this year compared with an increase of 4.8% for the industry.
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Skyrizi, along with another important new immunology drug, Rinvoq, demonstrated differentiated clinical profiles versus Humira and are expected to lower AbbVie’s dependence on Humira. Humira generated almost 37.4% of total sales in the first quarter of 2021. With many new indications coming in the next couple of years, sales of Skyrizi and Rinvoq could be higher and have the potential to replace Humira when generics are launched in 2023.
Per settlements with nine manufacturers like Biogen BIIB /Samsung Bioepis, Amgen AMGN, Sandoz (generic arm of Novartis [NVS]), among others, Humira biosimilars are expected to be launched in the United States in 2023. In the international markets, AbbVie is already facing direct biosimilar competition in Europe and other countries.
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AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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