Eli Lilly and Company and Incyte announced that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA), available as 4-mg, 2-mg and 1-mg tablets. The recommended dose is OLUMIANT 2-mg/day, with an increase to 4-mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4-mg/day. Once an adequate response is achieved on 4-mg/day, the dosage is to be decreased to 2-mg/day. OLUMIANT is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
“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.”
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 (≥50% scalp hair loss as defined by a Severity of Alopecia Tool (SALT) score ≥50). Across the studies at 36 weeks, 17-22% of patients taking OLUMIANT 2-mg/day and 32-35% of patients taking OLUMIANT 4-mg/day achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.1 Additionally, 11-13% of patients taking OLUMIANT 2-mg/day and 24-26% of patients taking OLUMIANT 4-mg/day achieved 90% or more hair coverage, compared to 1-4% of patients taking placebo; results for OLUMIANT 2-mg/day were not statistically significant under the multiplicity control plan for BRAVE-AA2.
Among patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking OLUMIANT 4-mg daily at 36 weeks.
The BRAVE-AA clinical program evaluated the safety profile of OLUMIANT. Few patients discontinued treatment due to adverse events (average of 2.2% across both studies) in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity. The most commonly reported adverse reactions (≥1%) were upper respiratory tract infections, headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, elevated liver enzyme levels, inflammation of hair follicles, 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. The U.S. FDA-approved labeling for OLUMIANT includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.1 See below for full Important Safety Information.
“Today marks a milestone with the first-ever FDA-approved systemic treatment for alopecia areata patients, who face significant challenges every day including limited public knowledge about the disease, a lack of treatment options and social stigma,”9 said Nicole Friedland, president and chief executive officer, National Alopecia Areata Foundation (NAAF). “The approval of OLUMIANT can spark hope for many patients and encourage new treatment conversations with their doctors. NAAF wants more choices for our patient community and with the approval of OLUMIANT, there are now new treatment expectations being established in alopecia areata care.”
Lilly is committed to ensuring patients have access to much-needed medicines and is working with insurers to do so. Through the OLUMIANT TogetherTM support program, Lilly offers a savings card for eligible commercially insured patients* to help with out-of-pocket costs where they pay as little as $5/month if covered by their insurance provider or $25/month if not covered by their plan.
“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved systemic medicine. In fact, a study published in 2017 of 1,083 people with AA showed that nearly 80 percent were unsatisfied with their treatment options,”10 said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer. “Our mission is to make life better for people living with debilitating immune-mediated diseases. OLUMIANT’s approval is a historic moment, and we’re delighted about what it can mean for adults with severe alopecia areata.”
OLUMIANT is a once-daily, oral JAK inhibitor discovered by Incyte and licensed to Lilly and is available through specialty pharmacies nationwide. Lilly also expects regulatory decisions for OLUMIANT in AA in the European Union and Japan in 2022.