The ACTT-2 study began on May 8 and included more than 1000 patients.
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The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
The FDA has granted Breakthrough Therapy designation to baricitinib (LY3009104; Lilly), an oral Janus Kinase (JAK) inhibitor, for the treatment of alopecia areata.
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
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).
Results from 2 studies show statistically significant improvement in scalp hair regrowth with baricitinib, a JAK inhibitor.
The approval was based on data from the phase 2/3 BRAVE-AA1 and phase 3 BRAVE-AA2 trials, which included adults with severe alopecia areata.
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.