The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to baricitinib (LY3009104; Lilly), an oral Janus Kinase (JAK) inhibitor, for the treatment of alopecia areata.

Alopecia areata is an autoimmune disorder that can cause unpredictable hair loss on the scalp, face and other areas of the body. The designation was based on positive interim data from the phase 2 portion of the phase 2/3 BRAVE-AA1 study, which evaluated the efficacy and safety of baricitinib in adults with severe or very severe alopecia areata for 36 weeks. The primary end point was the proportion of patients achieving Alopecia Areata Investigator Global Assessment (AA-IGA) 0 or 1 with a ≥2 point improvement.

Additionally, interim results showed no new safety signals with no serious adverse events reported. The most common treatment-emergent adverse events were found to be mild or moderate and included upper respiratory tract infections, nasopharyngitis and acne.

The Company is currently investigating baricitinib in the phase 3 portion of BRAVE-AA1, as well as the phase 3 BRAVE-AA2 study in patients with alopecia areata.

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“Patients with [alopecia areata] currently do not have any FDA-approved treatment options available to them,” said Lotus Mallbris, MD, PhD, VP of immunology development at Lilly. “We look forward to working with the FDA to further explore baricitinib’s potential to become the first approved treatment option for these individuals.”

Baricitinib is marketed under the brand name Olumiant and is currently approved for moderately to severely active rheumatoid arthritis in adults who have had an inadequate response to 1 or more tumor necrosis factor antagonists.

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