Baricitinib receives breakthrough therapy designation for alopecia areata
The FDA granted breakthrough therapy designation to baricitinib to treat patients with alopecia areata, according to a press release from Eli Lilly and Incyte.
“Patients with [alopecia areata] currently do not have any FDA-approved treatment options available to them,” Lotus Mallbris, MD, PhD, vice president of immunology development at Lilly, said in the release. “[Alopecia areata] not only causes hair loss but also may be a psychosocial burden for people living with this disease. ... 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 phase 2 portion of the BRAVE-AA1 study evaluated treatment with baricitinib (Olumiant) vs. placebo in adult patients, reporting no new safety signals or serious adverse events at week 36. Based on these positive results, the phase 3 portion of the BRAVE-AA1 study and the double-blind BRAVE-AA2 study are assessing efficacy and safety of 2 mg and 4 mg baricitinib doses vs. placebo.
Baricitinib is a once-daily, oral JAK inhibitor currently approved for the treatment of adults with moderate to severe rheumatoid arthritis.