Based on efficacy results from 2 phase 3 studies, Lilly has decided to discontinue development of baricitinib for lupus.
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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.
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).