FDA Grants Upadacitinib Breakthrough Therapy for Atopic Dermatitis

AbbVie today announced that the FDA granted breakthrough therapy designation to upadacitinib for adults with moderate-to-severe atopic dermatitis, according to a press release.

Upadacitinib is an investigational JAK1-selective inhibitor that demonstrated positive results in this population of patients. The new designation is supported by phase 2b clinical trial findings that were previously reported, according to the release.

AbbVie noted that upadacitinib has yet to receive FDA approval and its safety and efficacy are not yet confirmed for any indication.

More than 28 million Americans have the chronic inflammatory skin condition, which can present with skin erosion, oozing, crusting, redness, itching, and dry skin, according to AbbVie. Atopic dermatitis can have a significant impact on the physical and mental health of patients, demonstrating the need for novel therapies.

"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, MD, 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."

The results from the phase 3 SELECT-NEXT trial also showed that upadacitinib offers benefits for patients with rheumatoid arthritis (RA).

AbbVie reported that upadacitinib achieved the trial’s primary endpoints of ACR20 and reduced disease activity among patients with RA who had an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. Secondary endpoints, including ACR50, ACR70, and clinical remission, were also met, according to a press release.