The FDA approval is supported by Lilly’s BRAVE-AA1 and BRAVE-AA2 clinical trials, which evaluated the efficacy and safety of Olumiant in 1,200 adult patients with severe AA
Eli Lilly and Company (Lilly) and Incyte have secured the US Food and Drug Administration (FDA) approval for their Olumiant (baricitinib) to treat severe alopecia areata (AA) in adults.
Olumiant is a once-daily, oral (janus kinase) JAK inhibitor discovered by US-based biopharmaceutical company Incyte, and licensed to Lilly.
The drug is offered in 4mg 2mg, and 1mg dose strengths, with 2mg/day as recommended dose, and the increased 4mg/day in case of inadequate response.
The 4mg/day dose is considered for patients with nearly complete or complete scalp hair loss, regardless of a substantial eyelash or eyebrow hair loss.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Also, the FDA approval comes with a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.
Lilly senior vice president, Lilly Immunology and Lilly USA president, and chief customer officer Patrik Jonsson said: “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 per cent were unsatisfied with their treatment options.
“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.”
The FDA approval is supported by Lilly’s BRAVE-AA1 and BRAVE-AA2 clinical trials, which evaluated the efficacy and safety of Olumiant in 1,200 adult patients with severe AA.
In the studies, 17-22% of patients taking Olumiant in 2mg/day dose and 32-35% of patients taking 4mg/day achieved over 80% scalp hair coverage, compared to 3-5% with placebo.
In addition, 11-13% of patients taking Olumiant 2mg/day and 24-26% of patients taking 4mg/day achieved more than 90% hair coverage, compared to 1-4% with placebo.
Olumiant in 2mg/day dose strength did not show statistically significant results under the multiplicity control plan for BRAVE-AA2.
In patients with substantial eyebrow and eyelash hair loss at baseline, improvements in eyebrow and eyelash coverage were seen for patients taking a 4mg/day dose.
The most common adverse reactions in people taking the drug include headache, acne, high cholesterol levels, increases in blood markers related to the muscle, urinary tract infections, inflammation of hair follicles, and fatigue, among others.
BRAVE-AA program lead investigator Brett King said: “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. 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 2mg/day and one in three taking Olumiant 4mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking Olumiant 4mg/day with substantial eyebrow or eyelash hair loss.”