FDA approves first pill to treat alopecia

The United States Food and Drug Administration has approved the first systemic treatment for severe hair loss, alopecia areata.

The oral tablet, baricitinib, will treat the whole body rather than just one area, the FDA said in a statement Monday.

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Alopecia areata, often called alopecia, is an autoimmune disease. The body attacks its own hair follicles, causing them to fall out. It usually occurs in clumps, with patients losing large patches of hair at a time.

The announcement offers new hope to many people suffering from the disease, 300,000 of whom live in the United States.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, director of the division of dermatology and dentistry at the Center for Drug Evaluation and Research at the FDA.

Marcus added that the new treatment “will help address a significant unmet need for patients with severe alopecia.”

Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of one or more enzymes from a specific family, interfering with the pathway that leads to inflammation. This treatment was previously approved for use by the FDA in 2018 as a treatment for rheumatoid arthritis, but more recently doctors have used the drug to treat COVID-19 in some hospitalized adults.

In an attempt to reuse the drug, researchers tested Olumiant in two randomized, placebo-controlled trials (AA-1 trial and AA-2 trial) with hundreds of patients who had at least 50% scalp hair loss.

Patients in these trials received either a placebo, two milligrams of Olumiant, or four milligrams of Olumiant each day. The primary measure of effectiveness for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

In Trial AA-1, 22% of 184 patients who received two milligrams of Olumiant and 35% of 281 patients who received four milligrams of Olumiant achieved adequate hair coverage, compared to 5% of 189 patients who received placebo . the FDA said.

In the AA-2 trial, 17% of 156 patients who received 2 milligrams of Olumiant and 32% of 234 patients who received 4 milligrams of Olumiant achieved adequate hair coverage, compared to 3% of 156 patients who received a placebo.

However, the treatment comes with side effects, some of which include upper respiratory tract infections, acne, high cholesterol, and headaches. Patients may also experience nausea, anemia, weight gain, shingles, and inflammation of hair follicles.

The FDA does not recommend that the treatment be used in conjunction with other JAK inhibitors, biological immunomodulators, cyclosporine, or other strong immunosuppressants.

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