AbbVie, Inc. (ABBV - Free Report) announced that its investigational oral JAK inhibitor, upadacitinib met all primary as well as secondary endpoints in the fifth phase III study from its SELECT program.
The phase III study, SELECT-EARLY, evaluated the candidate for moderate-to-severe rheumatoid arthritis (RA) in patients who had not been previously treated with chemotherapy agent methotrexate (MTX) versus MTX monotherapy. The SELECT program evaluates more than 4,000 patients across six studies on RA.
After 12 weeks of treatment, the ACR50 response (primary endpoint) was achieved in 52% of the patients receiving the 15 mg oral once-daily dose of upadacitinib and 56% of the patients taking the 30 mg dose versus 28% for patients receiving MTX.
The second primary endpoint of clinical remission was achieved by 48% of the patients in the 15 mg dose arm and 50% in the 30 mg dose arm, at week 24, versus only 18% for MTX.
Meanwhile, 76% and 77% of patients in the 15 mg and 30 mg dose arm, respectively achieved ACR20 response at week 12 versus 54% for MTX.
The results clearly show that a significantly higher proportion of patients treated with upadacitinib in both doses achieved superior responses compared to MTX. This suggests that upadacitinib monotherapy has the potential to control progression of RA and reduce the risk of permanent bone and joint damage for MTX naive patients.
AbbVie plans to submit regulatory applications for upadacitinib in rheumatoid arthritis in the second half of the year.
Other than rheumatoid arthritis, upadacitinib is also being evaluated in late-stage studies for Crohn’s disease and psoriatic arthritis and mid-stage studies for atopic dermatitis, giant cell arteritis and ulcerative colitis.
JAK inhibitors, also known as Janus kinase inhibitors, are emerging as a potential treatment option for RA, eczema and other inflammatory diseases. These medicines work by inhibiting the activity of one or more of the Janus kinase family of enzymes
Last week, Eli Lilly (LLY - Free Report) and partner Incyte Corporation (INCY - Free Report) gained FDA approval for the lower dose of (2 mg) of their oral JAK inhibitor, Olumiant. While the FDA did not approve the higher dose (4 mg), the drug’s label was approved with a boxed warning stating risk of serious infections, malignancies and thrombosis. Olumiant is already marketed in Europe and Japan. Another JAK inhibitor available in the market to treat RA is Pfizer’s (PFE - Free Report) Xeljanz.
Successful development of upadacitinib will boost AbbVie’s RA portfolio, especially as biosimilar competition looms for its blockbuster RA drug, Humira.
Humira accounts for 65% of AbbVie’s sales. Amgen and Samsung Bioepis/Biogen’s Humira biosimilars will be launched in the United States in 2023 and in the EU in 2018.
AbbVie’s shares have gained 2.6% this year so far against the industry’s decline of 4.1%.
AbbVie currently carries 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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