Lilly wins FDA approval for treatment for hair loss caused by autoimmunity

The Food and Drug Administration on Monday approved an Eli Lilly drug that is the first-ever treatment for alopecia areata, an autoimmune disorder that triggers sudden hair loss.

The once-daily pill, known as Olumiant, was approved after clinical trials showed that treated patients regrew much of their lost hair. Patrik Jonsson, Lilly’s president of immunology, called the approval a historic moment for patients who until now have had to rely on cosmetic solutions, unapproved creams, and injections to manage the disease.

“When we meet with clinicians and thought leaders from across the U.S. and outside the U.S., we know that the need is huge,” Jonsson said. “We know that there are patients in line for treatments like Olumiant.”

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People with alopecia areata have an autoimmune response that attacks their own hair follicles, resulting in patchy hair loss across the scalp, eyebrows, and eyelashes. In some cases, the disease can progress to total hair loss across a person’s body.

There are about 700,000 people in the U.S. who live with the disorder; 300,000 of them have a severe form, meaning they’re missing at least half the hair on their scalp. And that’s the group that Lilly’s drug has been approved to treat.

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The company turned to a therapeutic that’s proven successful before: Olumiant, a small molecule inhibitor of a class of signaling proteins called Janus kinases. These proteins, known as JAKs, influence how cells grow and behave, and blocking them can help tamp down overactive inflammatory signals.

The drug has been approved for moderate to severe rheumatoid arthritis in a number of countries, including the U.S., and has been approved elsewhere for atopic dermatitis, a painful and itchy skin rash often triggered by an allergic reaction. In May, the FDA approved the drug for some hospitalized Covid-19 patients. Jonsson estimates that more than a million patients have been treated with the drug worldwide.

The company tested Olumiant’s usefulness in treating alopecia areata in a pair of randomized Phase 3 trials that recruited 1,200 participants with severe hair loss. Study participants received either a placebo or a daily tablet that contained a 2-milligram or 4-milligram dose of the drug.

After 36 weeks, about 40% of patients given the higher dose of Olumiant grew back enough hair to cover at least 80% of their scalp, compared to 20% of those on the lower dose and less than 6% of those in the placebo group. Those results, reported in the New England Journal of Medicine in May, were statistically significant. Patients taking the drug also regrew hair along their eyebrows and eyelashes.

The most common side effects were a headache, acne, and an upper respiratory tract infection. Jonsson said that about a third of severe alopecia areata patients in the U.S. would be good candidates for the treatment based on the trade-off between the drug’s benefits and side effects.

The drug’s list price at 2 milligrams will remain around $2,500 for a one-month supply. Jonsson said the company is still determining the price for 4 milligrams. He added that Lilly is committed to making sure out-of-pocket costs are as little as $5 a month for insured patients and $25 for the uninsured.

Last year, Lilly brought in $1.1 billion in revenue from Olumiant sales. Market projections for alopecia areata are modest, with investment banking firm Mizuho Securities forecasting revenues could reach $259 million in the U.S. and $154 million in Europe by 2030. Lilly is awaiting approval decisions in Europe and Japan during the second half of this year.

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