AbbVie (ABBV) Announced Positive Phase III RA Candidate Data
AbbVie Inc. ABBV announced positive top-line results from a phase III study on rheumatoid arthritis candidate, upadacitinib (ABT-494). Upadacitinib is an investigational oral JAK1-selective inhibitor being studied as a once-a-day oral therapy.
AbbVie’s shares have rallied 13.2% in the past one year, outperforming the Zacks classified Large Cap Pharmaceuticals industry’s 1.7% rise.
The multi-center, randomized, double-blind, placebo-controlled parallel group SELECT-NEXT study evaluated the efficacy and safety of two doses (15 mg and 30 mg) of upadacitinib versus placebo over 12 weeks in adult patients with moderate-to-severe rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic DMARDs and have had an inadequate response to them.
The study met its primary endpoint and all secondary endpoints with highly statistically significant and clinically meaningful results for both the doses compared to placebo.
The results showed that 64% of patients, receiving 15 mg and 66% of patients, administered 30 mg dose once daily, achieved ACR20 responses after 12 weeks of treatment compared to 36% of patients receiving placebo. Low disease activity was achieved by 48% of the patients receiving either dose of upadacitinib compared to 17% for placebo.
Upadacitinib is also being investigated in a pivotal study for psoriatic arthritis. Other studies are also ongoing for the treatment of Crohn's disease, ulcerative colitis and atopic dermatitis.
AbbVie’s flagship RA drug Humira brought in sales of $4.1 billion. However, the RA market is extremely crowded including drugs like Johnson & Johnson’s Simponi and UCB’s Cimzia among others.
We note that upadacitinib is a JAK1 inhibitor as second-line treatment for RA patients where drugs like Humira have inadequate response. However, Eli Lilly and Company’s LLY JAK inhibitor, Olumiant was recently approved in the EU and Pfizer Inc.’s PFE Xeljanz is marketed in the U.S. for treating RA by inhibiting JAK enzyme.
Meanwhile, Amgen Inc. AMGN has already received approval to market a Humira biosimilar but the drug has not been launched due to ongoing litigation. If upadacitinib is approved, it may reduce the potential negative impact of Humira generics on the company’s top line.
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AbbVie currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks Rank #1 (Strong Buy) stocks here.
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