Abbvie Inc. (ABBV), a biopharmaceutical company, on Tuesday submitted a supplemental new drug application to the FDA seeking approval to expand the use of RINVOQ for the treatment of Alopecia areata.
Alopecia areata is a chronic immune-mediated disease marked by hair loss patterns in males and females. It may have profound physical and psychological effects on those affected.
The supplemental new drug application submission is based on Phase 3 trial data showing that RINVOQ helped patients achieve a SALT score of 20 or lower after 24 weeks of treatment, indicating significant scalp hair coverage, with continued improvement up to week 52. It is also the first JAK inhibitor to achieve complete scalp hair regrowth (SALT = 0) at week 24.
RINVOQ (upadacitinib), a JAK inhibitor, is already approved for the treatment of rheumatoid arthritis, psoriatic arthritis, atopic dermatitis, ulcerative colitis, Crohn's disease, ankylosing spondylitis, non-radiographic axial spondyloarthritis, polyarticular juvenile idiopathic arthritis, and giant cell arteritis.
The company is also testing RINVOQ in Phase 3 trials for hidradenitis suppurativa (HA), Takayasu arteritis, systemic lupus erythematosus (SLE), and vitiligo.
ABBV closed Tuesday at $197.69, up 0.16%. In the overnight market, shares are currently trading at $198.20, up 0.26%.
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