Lilly and Incyte Report Results of Baricitinib in P-III BRAVE-AA1 Study for Severe Alopecia Areata

Shots:

• The second P-III BRAVE-AA1 trial involves assesing the efficacy and safety of Baricitinib (2mg/4mg, qd) vs PBO in adults with a SALT score ≥ of 50 (i.e., who had ≥50% scalp hair loss) in addition to current episode of severe AA lasting at least 6mos. but no >8yrs.
• The P-III study met its 1EPs @36wks. i.e. 80% improvement in scalp hair regrowth, more scalp hair coverage (35%/ 22% vs 5%. The data are consistent with findings from the first P-III BRAVE-AA2 trial, results will be submitted to peer-reviewed journals.
• Lilly plans to submit sNDA to the FDA for baricitinib in H2’21, followed by submission to other regulatory agencies globally

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