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AbbVie’s Upadacitinib Meets Primary Endpoint in Phase IIb

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AbbVie’s ABBV shares have increased more than 6% after the company announced that its oral JAK-1 selective inhibitor, upadacitinib (ABT-494), met primary endpoints in a phase IIb study for treatment of adult patients with atopic dermatitis, also known as eczema. The company plans to advance the candidate into phase III studies next year.

AbbVie’s shares have outperformed the industry year to date. The stock has surged 30.6% compared with the industry’s 14.5% rally during the period.

The phase IIb, randomized, placebo-controlled, dose-ranging study was designed to evaluate the safety and efficacy of three doses (30 mg, 15 mg and 7.5 mg once-daily) of upadacitinib in patients with the aforementioned indication. The study met its primary endpoints across all dose groups with highly statistically significant and clinically meaningful results compared with placebo.


The study’s primary outcome was the mean percentage change in Eczema Area and Severity Index (EASI) score, a tool used to measure the extent of disease severity. In the trial, upadacitinibshowed greater mean percentage change from baseline in EASI score compared with placebo at 16 weeks. Also, 50% of patients receiving 30 mg once-daily dose of upadacitinib showed almost clear skin. Additionally, the study met secondary endpoints, demonstrating a significant reduction in skin-itching.

Upadacitinib is also being investigated in six phase III studies for rheumatoid arthritis. Other researches are also underway for treatment of Crohn’s disease, ulcerative colitis and psoriatic arthritis.

Per National Eczema Association, around 31.6 million people in the United States have some form of atopic dermatitis. Of them, 4.1 million children are affected by the disease. Hence, approval of the drug will provide the company with access to a huge patient population suffering from the disease in the United States.

Notably in March, Regeneron Pharmaceuticals, Inc. REGN along with partner Sanofi SNY had launched Dupixent (dupilumab) Injection for treating atopic dermatitis. Thus, upadacitinib awaits a combat against competitive pressure in the market, once approved.

Zacks Rank & Stocks to Consider

AbbVie currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the pharma sector is Aduro Biotech, Inc. ADRO, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Aduro Biotech’s loss per share estimates reduced from $1.46 to $1.32 for 2017 and from $1.26 to $1.24 for 2018 over the last 30 days. The company delivered positive surprises in two of the trailing four quarters with an average beat of 2.53%.

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