Eli Lilly and Incyte have announced that its jointly developed drug Olumiant (baricitinib) has been approved by the US Food and Drug Administration (FDA) as a first-in-disease systemic treatment for adults with severe alopecia areata (AA).
The FDA based its decision on the BRAVE-AA clinical programme – BRAVE-AA1 and BRAVE-AA2 trials – the largest phase 3 AA clinical study completed to date, which assessed the safety profile of Olumiant.
The double-blind, placebo-controlled trials enrolled 1,200 patients with severe AA and were randomised to receive a once-daily dose of Olumiant 2mg, Olumiant 4mg or placebo.
Across the studies at the 36 week marker, 17-22% of patients taking Olumiant as a 2mg a day dose and 32-35% of patients taking Olumiant a 4mg a day dose achieved 80% or more scalp hair coverage, compared to the 3-5% of participants taking placebo.
In addition to this, 11-13% of patients taking Olumiant 2mg a day dose and 24-26% of patients taking Olumiant 4mg a day dose achieved 90% or more hair coverage, versus the 1-4% of patients taking placebo.
Brett King, associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA programme, 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.”
Few patients discontinued treatment due to adverse events in the 36-week placebo-controlled period and the majority of treatment-emergent adverse events were mild or moderate in severity.
Olumiant is a once-daily pill available as 4mg, 2mg and 1mg tablets, with the recommended dose being 2mg per day, with an increase to 4mg per day if treatment response proves inadequate.
A suggested dosed of 4mg per day is specifically for patients with almost complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, and this can be gradually reduced to 2mg a day with a satisfactory response.
The treatment is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Eli Lilly anticipates that regulatory decisions will be made for Olumiant in AA in the EU and Japan later this year.
