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.
Your search for baricitinib returned 36 results
The approval was based on data from the phase 3 ACTT-2 and COV-BARRIER studies.
Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
The applications are supported by data from two 2two phase 3 induction studies and one 1 maintenance study.
The revisions are based on a completed review of a large randomized safety clinical trial, which included 4362 patients with rheumatoid arthritis.
The update was based on data from the COV-BARRIER study.
Results from 2 studies show statistically significant improvement in scalp hair regrowth with baricitinib, a JAK inhibitor.
Findings showed that the trial did not meet statistical significance on the primary endpoint.
Both doses of baricitinib met the primary end point, demonstrating statistically significant improvement in scalp hair regrowth compared with placebo.
The EUA was granted based on data from the phase 3 ACTT-2 trial, which was conducted by the NIAID.