Global pharma powerhouse AbbVie has submitted a new application to the US FDA seeking approval of upadacitinib (RINVOQ) for the treatment of adults and adolescents with severe alopecia areata (AA). 

 

The filing is backed by results from the Phase 3 UP-AA clinical program.

 

“Alopecia areata is a chronic immune-mediated disease in which the physical and psychological burden patients can experience goes far beyond hair loss, impacting their day-to-day lives,” said Kori Wallace, vice president, global head of immunology clinical development, AbbVie. 

 

“In the UP-AA clinical program, upadacitinib showed early and substantial scalp hair growth, including complete scalp hair coverage, which is a significant outcome for those living with this often-overlooked disease.”

 

The UP-AA program included two replicate Phase 3 studies. Each featured a 24-week double-blind, placebo-controlled period, followed by a blinded extension through 52 weeks, with longer-term results reported descriptively.

 

Across the trials, the mean baseline Severity of Alopecia Tool (SALT) score was 84, and about 51% of patients (716 of 1,399) had SALT scores ≥95, indicating near-total or total scalp hair loss at study start.

 

Both primary and key secondary endpoints were met at Week 24, with SALT ≤20 and SALT = 0 achieved for both the 15 mg and 30 mg doses of upadacitinib. Response rates continued to improve through Week 52.