First anti-patchy hair loss drug approved in the EU | City of health Berlin

Friday 8 July 2022 – Author: ham

Baricitinib has been approved in the EU for the treatment of severe alopecia areata. Immune mediated disease is characterized by circular hair loss. The JAK inhibitor is the first drug that appears to help.

A few days after the FDA, the European Commission also approved the Janus kinase inhibitor baricitinib (trade name Olumiant) for the treatment of severe alopecia areata. Alopecia areata is a chronic immune-mediated disease characterized by acute or chronic hair loss. Circular hair loss on the head is typical, but it can also lead to the loss of all body hair. Men and women are equally affected. To date, no satisfactory treatment options are available for patients. The active ingredient baricitinib, originally developed for the treatment of rheumatoid arthritis, is the first drug that appears to help.

Possible re-hair of the scalp

The results of the study show that at least 80% of scalp regrowth is possible with baricitinib. “These are encouraging results,” says Prof. Michael Hertl, President of the German Dermatological Society (DDG). “With baricitnib we can now treat severe alopecia areata in a targeted way. For patients, this means a return to their quality of life, because hair loss puts a strain on the psyche and associated stigmatization, “says the dermatologist.

One pill a day

In two double-blind, randomized, placebo-controlled approval studies (BRAVE-AA1 and BRAVE-AA2), the JAK inhibitor was shown to be significantly more effective than placebo. The main focus was on how the drug affects the regrowth of the hair on the head. In both studies, hair regrown in 35.9-38.8% of study participants who received a 4 mg dose of baricitinib. This compares with 22.8 percent of BRAVE-AA1 and 32.6 percent of BRAVE-AA2 at a dose of 2 mg of baricitnib. In the placebo groups, the percentage ranged from 6.2 to 16.6 percent. Based on these results, baricitinib was then approved at the highest dose of 4 mg. The drug is administered in the form of a tablet once a day.

Not without side effects

Baricitinib treatment is considered safe, but it is not free from side effects. For example, there are reports of elevated cholesterol levels, respiratory and urinary tract infections, headaches, shingles (shingles), and herpes infections on the skin.

The JAK baricitinib inhibitor has been approved for the treatment of rheumatoid arthritis since 2017. A first extension of the approval took place in 2020 for neurodermatitis. The tablet is also used in severe cases of Covid because it can apparently slow down excessive immune reactions.

The DDG predicts that additional JAK inhibitors will receive approval for the indication of severe circular hair loss.

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