AbbVie's Upadacitinib Granted Breakthrough Therapy by FDA

JANUARY 08, 2018
Jenna Payesko
FDA, Upadacitinib, AbbVie, breakthrough therapyThe US Food and Drug Administration (FDA) has granted breakthrough therapy designation for the investigational, once-daily oral JAK1-selective inhibitor ABT-494 (upadacitinib) in adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy, announced AbbVie.

The breakthrough designation is supported by positive phase 2b study results released in September 2017, where the study met the primary endpoint, a mean percentage change in the Eczema Area and Severity Index (EASI) score versus the placebo at 16 weeks. The results at week 16 demonstrated that primary and second endpoints across all doses — 30/15/7.5 mg — improved significantly.

Within the first week, reduction in itch was observed and within the first 2 weeks improvement in the skin occurred. Clear or mostly clear skin was achieved by 50/31/14% of patients receiving 30/15/7.5 mg doses, measured by the Investigator Global Assessment (IGA) scale, compared to 2% of patients receiving placebo.

Positive results were demonstrated, and no new safety signals were found.

“Current treatment options for people living with atopic dermatitis are limited, and addressing these patients needs is important to us,” Michael Severino, MD, executive vice president, research and development, chief scientific officer, AbbVie, said in a statement. “We look forward to advancing upadacitinib into phase 3 studies for atopic dermatitis soon.”

The breakthrough therapy designation program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicates the treatment under review may demonstrate substantial improvement over current therapies on one or more clinically significant endpoints.

Andrew Alexis, MD, MPH, an associate professor of dermatology at the Icahn School of Medicine, and the dermatology chair at Mount Sinai St. Luke’s, sat with MD Magazine to discuss the current state of atopic dermatitis. 

"This turns out to be a very exciting time in the treatment of atopic dermatitis," Alexis said. "For the first time in many years, we have new therapies that are non-corticosteroid based that can have a tremendous impact on our patients with atopic dermatitis."



Upadacitinib is not yet approved by regulatory authorities, and safety and efficacy are not yet established.

Phase 3 trials of upadacitinib in rheumatoid arthritis and psoriatic arthritis are ongoing. AbbVie plans to continue testing the drug’s potential to treat conditions like Crohn’s disease, ulcerative colitis and ankylosing spondylitis.

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