Regulatory Affairs

AbbVie’s Upadacitinib gets FDA breakthrough designation for atopic dermatitis

Published 09 January 2018

AbbVie’s investigational, once-daily oral JAK1-selective inhibitor upadacitinib (ABT-494) has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for the treatment of adult patients with moderate to severe atopic dermatitis who are candidates for systemic therapy.

This Breakthrough Therapy Designation is supported by positive Phase 2b results previously announced in September 2017,11 and marks 13 Breakthrough Therapy Designations granted to AbbVie's investigational treatments since the company's inception in 2013. Upadacitinib is not approved by regulatory authorities and its safety and efficacy have not been established.

Atopic dermatitis, a chronic inflammatory skin disease, is characterized by skin erosion, oozing and crusting, redness, intense itching (pruritus) and dry skin. Symptoms can appear as a rash on the skin, or the skin may become thickened and leathery.

The FDA's Breakthrough Therapy Designation program is intended to expedite the development and review of medicines with preliminary clinical evidence that indicate that the investigational treatment may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.

"Our history, scientific expertise and leadership in immunology drive our focus to develop new treatment approaches that address urgent and unmet needs," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "Current treatment options for people living with atopic dermatitis are limited, and addressing these patient needs is important to us. We look forward to advancing upadacitinib into Phase 3 studies for atopic dermatitis soon."

In the U.S. alone, atopic dermatitis affects an estimated 28 million people of all ages, and can have a significant impact on the physical and psychosocial health of patients.

AbbVie will present additional data from the Phase 2b trial at upcoming scientific congresses.

Source: Company Press Release