The MHRA has granted marketing authorisation for Eli Lilly’s baricitinib (Olumiant), the first licensed JAK inhibitor for the treatment of severe alopecia areata in adult patients.
The authorisation was based on BRAVE-AA1 and BRAVE-AA2 studies which both met the primary endpoint of the proportion of patients achieving SALT ≤20 (i.e., 80% or more scalp hair coverage) at week 36.
In pooled data from both studies, 34% of patients taking baricitinib 4mg achieved 80% or more scalp hair coverage compared to 4.1% of patients taking placebo at week 36.
“Alopecia areata is an often-misunderstood autoimmune disease that can lead to unpredictable hair loss, ranging from bald patches to complete loss of all hair,” said Dr Paul Farrant, Consultant Dermatologist.
“This is an important authorisation for patients as previously there has never been a licensed oral therapy for adults with severe alopecia areata.”
Sue Schilling, Chief Executive of Alopecia UK, also welcomes the news: “This authorisation may lead to further treatment options now being offered to those eligible patients struggling with alopecia areata,” she said.
“We will continue to ensure our voice is heard where appropriate and will try to demonstrate the psychological, social and financial impacts that alopecia areata can have to a person’s life to emphasise the importance of having access to treatments.”
