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AbbVie’s Upadacitinib Gains Breakthrough Therapy Designation


AbbVie ABBV announced that the FDA has granted Breakthrough Therapy Designation (“BTD”) to its investigational JAK1 inhibitor, upadacitinib (ABT-494) for the treatment of severe atopic dermatitis

The designation aims to expedite the development and review of drugs intended to treat serious or life-threatening conditions and provide patients access to these as soon as possible.

AbbVie’s shares have increased 55.2% in the past year, outperforming the industry’s gain of 16.3% during that period.

The FDA has granted the BTD designation to upadacitinib based on positive data from a phase IIb study announced in September 2017.

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 study, upadacitinib showed greater mean percentage change from baseline in EASI score compared with placebo at 16 weeks. Also, 50% of the 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 studies are also underway for the treatment of Crohn’s disease, ulcerative colitis and psoriatic arthritis.

Per National Eczema Association, around 28 million people in the United States are affected with atopic dermatitis.

We remind investors that Regeneron Pharmaceuticals, Inc. REGN along with partner Sanofi SNY had launched Dupixent injection for treating atopic dermatitis early in 2017. Thus, upadacitinib has to contend with competitive pressure in the market, once approved.

Zacks Rank & Stocks to Consider

AbbVie carries a Zacks Rank #3 (Hold).

A better-ranked stock in the pharma sector is Celldex Therapeutics, Inc. CLDX, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Celldex’s loss estimates remained stable at 93 cents for 2017 and at 90 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 15.36%.

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