Lilly's Baricitinib Approved in China for Severe Alopecia Areata, Demonstrating Up to 90% Hair Regrowth

On March 27, Eli Lilly and Company announced that Olumiant (baricitinib tablets) has been officially approved by the regulatory authority for systemic treatment of severe alopecia areata in adults. Notably, Olumiant is also the first and only innovative targeted drug in China for systemic treatment of severe alopecia areata.

Alopecia Areata is an autoimmune hair loss disease, with typical clinical manifestations of patchy hair loss, presenting as round or oval, well-defined bald patches, which can affect any hair-bearing area, including the scalp, eyebrows, eyelashes, and some patients may experience changes in the fingernails or toenails. In recent years, the prevalence of Alopecia Areata has shown an increasing trend year by year, with severe cases progressing to total alopecia or universal alopecia. Severe Alopecia Areata is stubborn, difficult to treat, prone to recurrence, and seriously affects the mental health and quality of life of patients. Previous treatments mainly involved oral and topical corticosteroids, which, although somewhat effective, also come with many side effects, and most patients are dissatisfied with the treatment.

Baricitinib is an orally administered JAK inhibitor taken once daily, initially developed by Incyte. In December 2009, Eli Lilly and Company reached an agreement with Incyte to co-develop and commercialize the product in a deal worth up to $755 million, including a $90 million upfront payment and up to $665 million in milestone payments.

The approval was based on data from the BRAVE-AA1 and BRAVE-AA2 Phase III clinical trials. A total of 1,218 patients were enrolled in the two studies and received 52 weeks of treatment. The results showed that approximately 39% of patients taking 4mg of baricitinib achieved 80% or greater scalp hair coverage. Of these patients, about 74% achieved 90% hair coverage at week 52. Additionally, over 40% of patients experienced small hair growth in eyebrow and eyelash gaps.

In patients taking 2mg of Baricitinib, approximately 22% achieved significant scalp hair regrowth, with about 67% of patients reaching 90% or greater hair coverage by week 52. Additionally, about 23% and 25% of patients experienced regrowth of eyebrows and eyelashes, respectively.

Dr. Li Wang, Senior Vice President of Eli Lilly and Company and Head of Lilly China Drug Development and Medical Affairs Center, stated: "As the first targeted drug for systemic treatment of adult severe alopecia areata, the approval of the new indication for Olumiant fills an urgent unmet medical need for patients with severe alopecia areata in China and provides doctors with a new clinical treatment option. The BRAVE-AA2 study demonstrated the efficacy and safety of Olumiant in a global population, including Chinese patients. Moving forward, Eli Lilly and Company will continue to explore the dermatology field, committing to the research and development of innovative drugs to bring more breakthrough treatments to patients in China."

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