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Eli Lilly receives marketing authorisation for baricitinib

Treatment involves adult patients with severe alopecia areata.

Eli Lilly has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation for baricitinib – also known as Olumiant – for the treatment of severe alopecia areata in adult patients.

Marketing authorisation was based on BRAVE-AA1 and BRAVE-AA2 studies which both used the Severity of Alopecia Tool (SALT) score and both met the primary endpoint among the proportion of patients.

Meanwhile, achievement of full regrowth or regrowth with minimal gaps in eyebrow and eyelash hair was also seen, with baricitinib, for patients who at baseline had significant gaps or no notable eyebrows or eyelashes, as compared to patients taking placebo

Sue Schilling, chief executive of Alopecia UK, welcomed the news: “This authorisation may lead to further treatment options now being offered to those eligible patients struggling with alopecia areata.

“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 on a person’s life to emphasise the importance of having access to treatments.”

“This authorisation establishes baricitinib as the first JAK inhibitor to be authorised in Britain for the treatment of adults with severe alopecia areata and reflects our commitment to immunological diseases with high unmet need,” concluded Dr Jeff Yang, associate vice president at Eli Lilly.

“We understand the importance of establishing a novel treatment option for eligible patients and Lilly would like to thank the patients and investigators around the world who have made this possible,” he added.

Baricitinib has now become the first licensed JAK inhibitor for the treatment of severe alopecia areata.