Recently, The U.S. Food and Drug Administration(FDA) approved the use of baricitinib. Baricitinib is a drug that restores hair growth and reverses hair loss made by Eli Lilly and Company, an American Pharmaceutical company headquartered in Indianapolis. This drug will help patients regrow their hair by blocking the immune system from attacking hair follicles. It is the first approved treatment for severe alopecia areata, a disfiguring skin disease.

More than 300,000 Americans live with severe alopecia areata, according to the F.D.A. This is an autoimmune disorder that affects about 7 million people in the United States. The immune system of patients with alopecia areata attacks the hair follicles and leads to complete loss of scalp hair and sometimes eyebrows, eyelashes, facial hair, and body hair.

FDA Approves First Alopecia Drug That Restores Hair Growth in Many Patients
Brett King

Dr. Brett King is an associate professor of dermatology at Yale Medical School who worked with Eli Lilly and Company to conduct a series of clinical trials with the new baricitinib medicine. This is a once-daily pill that goes by the product name Olumiant.

The Olumiant was studied in two trials involving 1,200 patients with alopecia areata and the result was surprising. Around 40% of the patients who took the Lilly Drug had complete or near-complete regrowth of hair within 36 weeks. After a year, nearly 50% of the patients had complete regrowth of their hair. Yes, this result is so uplifting because Olumiant helped one in three patients with severe alopecia areata regrow their hair.


Half of the patients who had no scalp hair at the starting point of the trials got 80% or more scalp coverage. Patients with significant eyebrow or eyelash hair loss also had improvements.

The trial results of the drug“are impressive,” wrote Dr. Andrew Messenger of the University of Sheffield in an accompanying editorial. The findings “represent the first published phase 3 trials of any treatment for this condition.”

FDA Approves First Alopecia Drug That Restores Hair Growth in Many Patients
Half of the patients who had no scalp hair at the starting point of the trials got 80% or more scalp coverage


Dr. Brett King explained: “Until now, there have been no FDA-approved treatments for alopecia areata and the medicines that have been used in the past to treat severe cases of alopecia areata are largely ineffective. There is, however, lots of data to show that a relatively new class of medicines called JAK inhibitors work for the treatment of severe alopecia areata. Patient access to these medicines is extremely limited, though, because JAK inhibitors were not FDA-approved for this purpose. FDA approval will bring greater access, via insurance coverage, to patients.”

He continued: “When a medicine is approved for the treatment of a disease, doctors feel more comfortable prescribing the medicine for that purpose. Therefore, FDA approval will empower and enable health care providers to treat patients with severe alopecia areata.”

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King says about the first patient he treated. “He had almost no scalp hair, his eyebrows, eyelashes, and facial hair were missing, and, in addition, he had red, scaly psoriasis plaques all over his body. It was in 2013… I explained to the patient that the use of tofacitinib in him would be exploratory, and he agreed to try it…. Not long after he started taking tofacitinib, his hair started to grow. I published the results of his treatment not long after that and history was made, forever changing this disease.”

Dr. Maryanne Makredes Senna, the director of the Hair Loss Center of Excellence at Beth Israel Lahey Health in Massachusetts said: “It’s a beautiful thing to see the amazing impact. They come in with no hair, totally withdrawing from life. Their eyes are cast down. They come back and say, ‘I have my life back. I have myself back.’”

The results of the recent trials were published in the New England Journal of Medicine.

Source: YaleNews


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