Eli Lilly and Incyte have secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for baricitinib to treat alopecia areata (AA).
AA is an autoimmune disorder, which may result in an unpredictable hair loss on the scalp, face and other areas of the body.
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.
According to the company, there were no new safety signals with no serious adverse events observed in the phase 2 portion of the BRAVE-AA1 study up to week 36.
Based on the interim data of the phase 2 part of the study, the phase 3 portion of BRAVE-AA1 and an additional phase 3 BRAVE-AA2 double-blind study are presently evaluating the efficacy and safety of the 2-mg and 4-mg doses of baricitinib relative to placebo.
Baricitinib is a once-daily and oral JAK inhibitor, which is already approved to treat adults with moderately to severely active rheumatoid arthritis (RA).
Marketed as Olumiant, the baricitinib is approved in more than 65 countries across the US, member states of the EU and Japan.
Lilly immunology development vice president Dr Lotus Mallbris said: “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.”
Recently, Boehringer Ingelheim and Eli Lilly have secured fast track status from the FDA for the investigation of Jardiance (empagliflozin) to treat chronic kidney disease.
The designation will help investigate the efficacy of Jardiance to minimise the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease.