The Food and Drug Administration on Monday approved a drug that restores hair growth and can serve as a treatment for alopecia areata.
Why it matters: The FDA said it was the first systemic treatment for the condition, which affects more than 300,000 people each year.
Alopecia is an autoimmune disease The body attacks the hair follicles, causing large clumps of hair to fall out. Approximately 6.8 million people in the United States currently suffer from alopecia.
Designation: The newly approved drug, called Olumiant, is an oral pill from drugmaker Eli Lilly that regrows hair by blocking the immune system from attacking those follicles.
- Olumiant has been tested in two studies involving 1,200 patients with this condition. About 40% of patients taking the drug had full or almost full hair growth after 36 weeks.
- After a year, about half of the patients had all their hair back.
By Numbers: According to the FDA, in the first study, 22% of 184 patients who received 2 milligrams of the drug and 35% of 281 patients who received 4 milligrams had “adequate scalp hair.”
- The study found that of the 189 patients taking the placebo, 5% experienced hair regrowth.
- In the second study, 17% of the 156 patients who received 2 mg and 32% of the 234 patients who received 4 mg had adequate skull coverage.
- Meanwhile, 3% of the 156 patients who received placebo in the second study had adequate coverage.
oily Comes with an alert box for certain side effects and mortality, serious infections, and serious cardiovascular events, among other possible issues.
What do you say: “Access to safe and effective treatment options is critical for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry at the FDA’s Center for Drug Evaluation and Research, in a statement.
- “Today’s approval will help fill an important unmet need for patients with severe alopecia.”