Approval Announcement
INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) and Incyte (NASDAQ: INCY) announced that the U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib) — a once-daily pill — as the first-in-disease systemic treatment for adults with severe alopecia areata (AA).
Dosage Forms and Recommended Dose
Dosage Forms: 4-mg, 2-mg, and 1-mg tablets
Recommended Dose:
Initial dose: 2 mg/day; increase to 4 mg/day if the treatment response is inadequate.
For patients with nearly complete or complete scalp hair loss (with or without substantial eyelash/eyebrow loss), consider initiating treatment with 4 mg/day.
Once an adequate response is achieved with 4 mg/day, reduce the dosage to 2 mg/day.
Contraindicated Combinations: Olumiant is not recommended for use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Expert Commentary
"People with alopecia areata, dermatologists and other healthcare providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease. Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities," said Brett King, M.D., Ph.D., F.A.A.D., associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA program.
"I am so happy that adults with severe alopecia areata can now take Olumiant, a once-daily pill. The results of clinical trials are remarkable, as one in five adults taking Olumiant 2-mg/day and one in three taking Olumiant 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking Olumiant 4-mg/day with substantial eyebrow or eyelash hair loss."
Basis for Approval: BRAVE-AA Clinical Trials
The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials — the largest Phase 3 AA clinical trial program completed to date — evaluating the efficacy and safety of Olumiant in 1,200 adult patients with severe AA (defined as ≥50% scalp hair loss via Severity of Alopecia Tool [SALT] score ≥50).
Efficacy Results at 36 Weeks
80% or more scalp hair coverage:
17–22% of patients in the Olumiant 2-mg/day group
32–35% of patients in the Olumiant 4-mg/day group
3–5% of patients in the placebo group
90% or more scalp hair coverage:
11–13% of patients in the Olumiant 2-mg/day group (results not statistically significant under the BRAVE-AA2 multiplicity control plan)
24–26% of patients in the Olumiant 4-mg/day group
1–4% of patients in the placebo group
Eyebrow and Eyelash Improvements: Patients with substantial eyebrow/eyelash loss at baseline showed improvements with Olumiant 4-mg/day at 36 weeks.
Safety Profile
Treatment Discontinuation and Adverse Event Severity
Few patients discontinued treatment due to adverse events (average 2.2% across both trials) during the 36-week placebo-controlled period.
Most treatment-emergent adverse events were mild or moderate in severity.
Common Adverse Reactions (≥1%)
Upper respiratory tract infections, headache, acne, high cholesterol levels, increased muscle-related blood markers, urinary tract infections, elevated liver enzyme levels, hair follicle inflammation, fatigue, lower respiratory tract infections, nausea, genital yeast infection, low red blood cell counts, low white blood cell counts, abdominal pain, shingles, and weight increase.
Boxed Warning
The U.S. FDA-approved labeling for Olumiant includes a boxed warning for risks of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis.
