FDA Approves Baricitinib as First Oral Systemic Treatment for Severe Alopecia Areata

Today, the U.S. FDA announced the approval of the oral JAK inhibitor baricitinib, jointly developed by Eli Lilly and Company and Incyte Corporation, for the treatment of adult patients with severe alopecia areata. This is the first systemic therapy approved by the FDA for the treatment of alopecia areata.

Alopecia Areata: The Second Most Common Type of Hair Loss WorldwideAlopecia areata is the second most common type of hair loss worldwide, with approximately 147 million patients globally and about 4 million in China. It is an autoimmune disease where the immune system attacks hair follicles, causing partial or complete hair loss on the scalp, face, or other parts of the body. Alopecia areata often begins in childhood, and it can affect individuals of any age, gender, or ethnicity.

Baricitinib is an oral JAK inhibitor taken once daily. It has been approved in more than 75 countries and regions for the treatment of rheumatoid arthritis and in over 50 countries and regions for the treatment of moderate to severe atopic dermatitis. For the indication of alopecia areata, it received Breakthrough Therapy Designation and Priority Review status from the FDA.

▲The manifestations of a patient with severe alopecia before treatment and after 8 months of treatment with Baricitinib (Image source: Reference [2])

The efficacy and safety of Baricitinib were evaluated in two randomized, double-blind, placebo-controlled clinical trials. Patients participating in these trials had at least 50% hair loss at baseline for more than 6 months.

Trial results showed that after 36 weeks of treatment, approximately one-third of patients receiving 4 mg of baricitinib in two clinical trials achieved more than 80% scalp hair coverage (BRAVE-AA1=35.2%, BRAVE-AA2=32.5%), compared to 5.3% (BRAVE-AA1) and 2.6% (BRAVE-AA2) in the placebo groups. Meanwhile, about one-third of patients achieved complete regrowth or no obvious absence of eyebrows or eyelashes.

The most common side effects of Baricitinib include: upper respiratory tract infections, headache, acne, high cholesterol, elevated creatine phosphokinase, urinary tract infections, elevated liver enzymes, folliculitis, fatigue, lower respiratory tract infections, nausea, genital yeast infections, anemia, neutropenia, abdominal pain, herpes zoster, and weight gain.

"Having a safe and effective treatment option is crucial for patients suffering from severe alopecia areata," said Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry at FDA's Center for Drug Evaluation and Research (CDER). "Today's approval helps address a significant unmet need for patients with severe alopecia areata."

In addition to Baricitinib, Pfizer's JAK3/TEC inhibitor Ritlecitinib, Concert Pharmaceuticals' JAK1/2 inhibitor CTP-543, Zelgen Pharma's JAK inhibitor Jaktinib, and Reistone Biopharma's JAK1 inhibitor SHR0302 have also achieved positive results in clinical trials and are in the late stages of clinical development. It is hoped that these JAK inhibitors will progress smoothly in clinical trials and soon bring more treatment options for patients with alopecia areata.

References:

[1] FDA Approves First Systemic Treatment for Alopecia Areata. Retrieved June 13, 2022, from https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata

[2] Olamiju et al., (2019). Treatment of severe alopecia areata with baricitinib. JAAD case reports, DOI:https://doi.org/10.1016/j.jdcr.2019.07.005

Original Title: Can Restore 80% Hair Growth, FDA Approves First Oral Alopecia Areata Treatment