Both doses of baricitinib met the primary end point, demonstrating statistically significant improvement in scalp hair regrowth compared with placebo.
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The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
The ACTT-2 study began on May 8 and included more than 1000 patients.
Baricitinib, a JAK inhibitor, is currently approved in the US for rheumatoid arthritis.
The FDA has granted Breakthrough Therapy designation to baricitinib (LY3009104; Lilly), an oral Janus Kinase (JAK) inhibitor, for the treatment of alopecia areata.
Results showed that the 4mg dose of baricitinib plus TCS met the primary end point, with 31.5% of patients achieving EASI75 compared with 17.2% of patients in the placebo plus TCS group (P ≤.05).
Adding baricitinib to topical corticosteroids significantly improved disease severity in adult patients with moderate to severe atopic dermatitis, according to top-line results from BREEZE-AD7 study. The phase 3 study included 300 patients who had been diagnosed with moderate to severe atopic dermatitis for at least 12 months and had an inadequate response to topical medications.…
Lilly and Incyte announced positive top-line results from two Phase 3 clinical trials evaluating baricitinib for the treatment of adult patients with moderate to severe atopic dermatitis. Results from the BREEZE-AD1 and BREEZE-AD2 placebo-controlled trials showed that treatment with baricitinib monotherapy led to a statistically significant proportion of patients achieving Investigator’s Global Assessment for Atopic Dermatitis score of clear…
Data from a Phase 2 trial of baricitinib for the treatment of SLE supporting the Fast Track designation were published in The Lancet and presented at the European Congress of Rheumatology earlier this year.
The panel’s decision was based on four Phase 3 studies which evaluated the impact of baricitinib on RA signs and symptoms, physical function, joint damage progression and other patient-reported outcomes.