Eli Lilly and Incyte have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for baricitinib to treat alopecia areata (AA).

Alopecia areata is an autoimmune disorder that may lead to irregular hair loss on the scalp, face and other parts of the body. The disease usually develops during childhood and can be unique for everyone.

Marketed as Olumiant, baricitinib is an oral Janus kinase (JAK) inhibitor approved in more than 65 countries across the US, member states of the EU and Japan.

Baricitinib is already approved to treat moderately to severely active rheumatoid arthritis in adults who do not experience an adequate response to one or more TNF inhibitor therapies.

Eli Lilly immunology development vice-president Lotus Mallbris said: “Patients with alopecia areata currently do not have any FDA-approved treatment options available to them.

“AA not only causes hair loss but also may be a psychosocial burden for people living with this disease.

“At Lilly, we aspire to create new medicines that can give hope to patients. We look forward to working with the FDA to further explore baricitinib’s potential to become the first approved treatment option for these individuals.”

The latest FDA decision supports Phase 2 findings in the adaptive Phase 2 /3 BRAVE-AA1 clinical trial

The FDA has provided the status based on data of Lilly’s adaptive BRAVE-AA1 phase 2/3 study, which assessed treatment with baricitinib against placebo in adult patients with AA.

In the Phase 2 part of the trial, no new safety signals or serious adverse events were identified up to week 36.

Additionally, the treatment-emergent adverse events (TEAEs) were mild or moderate, with the most common events being upper respiratory tract infections, nasopharyngitis and acne.

Based on the interim data of the phase 2 part of the study, BRAVE-AA1’s phase 3 portion and an additional phase 3 BRAVE-AA2 double-blind study are presently evaluating the efficacy and safety of the 2mg and 4mg doses of baricitinib relative to placebo.