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# Lilly/Incyte Plan sNDA for Baricitinib in Alopecia
- URL: https://www.fdaweb.com/lilly-incyte-plan-snda-for-baricitinib-in-alopecia/
- Published: 2021-04-22T12:00:00.000Z
- Updated: 2026-09-14T16:55:55.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149171

Eli Lilly and and Incyte say they plan to file in the second half of this year a supplemental NDA for baricitinib in alopecia areata after reporting positive data from a second Phase 3 trial (BRAVE-AA1). They say the data are consistent with [findings](https://c212.net/c/link/?t=0&l=en&o=3134230-1&h=439835633&u=https%3A%2F%2Finvestor.lilly.com%2Fnews-releases%2Fnews-release-details%2Fbaricitinib-first-jak-inhibitor-demonstrate-hair-regrowth-phase&a=findings&ref=fdaweb.com) from the first Phase 3 clinical trial, BRAVE-AA2, announced earlier this year. “In both investigational trials, a statistically significant proportion of patients treated with baricitinib achieved the primary endpoint of hair regrowth across the two dosing regimens at Week 36 compared to patients treated with placebo,” [they say](https://investor.lilly.com/news-releases/news-release-details/lilly-and-incytes-baricitinib-improved-hair-regrowth-alopecia?ref=fdaweb.com).  

  
Baricitinib is a once-daily, oral JAK inhibitor approved in the U.S. under the trade name Olumiant as a treatment for adults with moderate to severe rheumatoid arthritis. The proposed submission may face greater scrutiny due ongoing FDA safety concerns with JAK inhibitors ([see earlier story](https://www.fdaweb.com/jak-inhibitor-concerns-delay-lilly-pfizer-submissions/)). FDA recently extended the review period for a supplemental NDA for Olumiant (baricitinib) for treating adults with moderate to severe atopic dermatitis. 

  
The drug class concerns arose from an FDA-required safety study when Pfizer’s Xeljanz (tofacitinib) was approved in 2012 for rheumatoid arthritis. In [2/2019](https://www.fda.gov/drugs/drug-safety-and-availability/safety-trial-finds-risk-blood-clots-lungs-and-death-higher-dose-tofacitinib-xeljanz-xeljanz-xr?ref=fdaweb.com) and [7/2019](https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-boxed-warning-about-increased-risk-blood-clots-and-death-higher-dose-arthritis-and?ref=fdaweb.com), FDA warned that interim trial results showed an increased risk of blood clots and death with the 10 mg twice daily dosage, and as a result, approved a *Boxed Warning.* The clinical trial is now complete and initial results show a higher occurrence of serious heart-related events and cancer in rheumatoid arthritis patients treated with both the 5mg and 10mg doses of tofacitinib compared to patients treated with a TNF inhibitor. FDA is awaiting additional results from the trial.