AbbVie submits upadacitinib to the FDA for alopecia areata after Phase 3 data showed up to 55% response at week 24 and sustained hair regrowth through 52 weeks.
Written by: Farha Farheen, Pharm D
Reviewed By: Pharmacally Editorial Team
AbbVie has submitted a supplemental application to the U.S. Food and Drug Administration seeking approval of upadacitinib (RINVOQ) for the treatment of adult and adolescent patients with severe alopecia areata, based on data from the Phase 3 UP-AA clinical program (NCT06012240).
The program comprised two replicate randomized, double-blind, placebo-controlled studies evaluating once-daily upadacitinib at 15 mg and 30 mg over 24 weeks, followed by a blinded extension through 52 weeks. Patients enrolled in the studies had advanced disease, with a mean Severity of Alopecia Tool (SALT) score of 84, and 51% presenting with SALT scores ≥95, indicating near-total or total scalp hair loss.
At week 24, both doses met the primary endpoint of achieving SALT ≤20, reflecting at least 80% scalp hair coverage, with response rates significantly higher than placebo. In Study 1, response rates were 45.2% and 55.0% for the 15 mg and 30 mg doses, respectively, compared with 1.5% for placebo; in Study 2, corresponding rates were 44.6% and 54.3% versus 3.4% for placebo. Complete scalp hair regrowth (SALT = 0), a key secondary endpoint, was also achieved in a proportion of patients treated with upadacitinib, with higher response rates observed at the 30 mg dose compared to 15 mg and placebo.
Treatment responses continued to improve through week 52 in the extension phase, with up to 63.8% of patients achieving ≥80% scalp coverage and up to 37.0% reaching complete regrowth.
The safety profile of upadacitinib at both dose levels remained consistent through 52 weeks and aligned with previously reported data. Upadacitinib is a selective Janus kinase (JAK) inhibitor with greater activity against JAK1, and is currently being studied across multiple immune-mediated conditions. Its use in alopecia areata is not yet approved and remains under regulatory review by both the FDA and the European Medicines Agency.
“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, M.D., Ph.D., vice president, global head of immunology clinical development, AbbVie. She added that in the UP-AA clinical program, upadacitinib demonstrated early and substantial scalp hair growth, including complete scalp coverage in some patients, indicating a clinically meaningful outcome for individuals living with the condition.
RINVOQ (upadacitinib), developed by AbbVie, is an oral Janus kinase (JAK) inhibitor with greater selectivity for JAK1 over other JAK enzymes. The therapy is being evaluated in multiple Phase 3 programs across immune-mediated diseases, including alopecia areata, hidradenitis suppurativa, Takayasu arteritis, systemic lupus erythematosus, and vitiligo.
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