November 27, 2022

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FDA approves oral JAK inhibitor baricitinib for the treatment of alopecia areata

FDA approves oral JAK inhibitor baricitinib for the treatment of alopecia areata



 

FDA approves oral JAK inhibitor baricitinib for the treatment of alopecia areata

On June 13, the U.S. Food and Drug Administration announced that it has approved the oral JAK inhibitor baricitinib, jointly developed by Eli Lilly and Incyte, for the treatment of adults with severe alopecia areata. This is the first systemic therapy approved by the FDA for the treatment of alopecia areata.

 

Alopecia areata is the second most common hair loss symptom in the world, with about 147 million patients worldwide..

It is an autoimmune disease that causes partial or complete loss of hair on the scalp, face, or other parts of the body as the immune system attacks the hair follicles.

Alopecia areata symptoms often start in childhood and can occur in people of any age, gender and race.

 

Baricitinib, a once-daily oral JAK inhibitor, has been approved for the treatment of rheumatoid arthritis in more than 75 countries and regions and is approved for the treatment of rheumatoid arthritis in more than 50 countries and regions Severe atopic dermatitis.

For the indications of alopecia areata, it has been granted breakthrough therapy designation and priority review status by the FDA.

 

FDA approves oral JAK inhibitor baricitinib for the treatment of alopecia areata

▲The performance of a previous patient with severe alopecia areata before treatment and after receiving baricitinib for 8 months (Image source: Reference [2])

 

 

The efficacy and safety of baricitinib were evaluated in two randomized, double-blind, placebo-controlled clinical trials.

At least 50% of the hair loss of patients enrolled in these trials at baseline was greater than 6 months.

 

Trial results showed that after 36 weeks of treatment, approximately one-third of patients treated with baricitinib at a dose of 4 mg in both clinical trials achieved more than 80% scalp hair coverage (BRAVE-AA1 = 35.2%). , BRAVE-AA2 = 32.5%), while the placebo group values ​​were 5.3% (BRAVE-AA1) and 2.6% (BRAVE-AA2).

 

At the same time, about one-third of patients achieved complete regrowth of eyebrows or eyelashes or no apparent loss.

 

The most common side effects of baricitinib include: upper respiratory tract infection, headache, acne, high cholesterol, elevated creatinine phosphokinase, urinary tract infection, elevated liver enzymes, hair follicle inflammation, fatigue, lower respiratory tract infection, nausea, genital yeast Infections, anemia, neutropenia, abdominal pain, shingles, and weight gain.

 

“Access to safe and effective treatment options is critical for patients suffering from severe alopecia areata,” said Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research (CDER). Significant unmet need for patients with alopecia areata.”

 

In addition to baricitinib, Pfizer’s JAK3/TEC inhibitor ritlecitinib and  Concert Pharmaceuticals’ JAK1/2 inhibitor CTP-543 have also achieved positive results in clinical trials and is in late-stage clinical development.

It is expected that these JAK inhibitors will progress smoothly in clinical trials and bring more treatment options to patients with alopecia areata as soon as possible.

 

 

 

 

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

FDA approves oral JAK inhibitor baricitinib for the treatment of alopecia areata

(source:internet, reference only)


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