The company turned to a treatment that had already proven successful: 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 reduce overactive inflammatory signals.
The drug has been approved for moderate to severe rheumatoid arthritis in several countries, including the US, and elsewhere for atopic dermatitisa painful, itchy skin rash often caused by an allergic reaction.
In May, the FDA approved the drug for some hospitalized patients with Covid-19 . Jonsson estimates that more than a million patients have been treated with the drug worldwide.
The company tested the usefulness of olumiant in the treatment of alopecia areata in a couple of phase 3 randomized trials recruiting 1200 participants with severe hair loss. Study participants received either a placebo or a daily tablet containing a 2-milligram or 4-milligram dose of the drug.
After 36 weeks, approximately 40% of the patients who received the higher dose of Olumiant regrown enough hair to cover at least 80% of your scalpcompared with 20% of those given the lower dose and less than 6% of those in the placebo group. Those results, published in the New England Journal of Medicine in May, they were statistically significant. Patients taking the drug also grew hair back along their eyebrows and eyelashes.
Most common side effects
The most common side effects were headache, acne, and upper respiratory tract infection. Jonsson said that about a third of patients with severe alopecia areata in the US would be good candidates for treatment based on the trade-off between the drug’s benefits and side effects.
The list price of the 2-milligram drug will continue to be around $2,500 for a one-month supply. Jonsson said the company is still determining the price of 4 milligrams. She added that Lilly is committed to making sure out-of-pocket costs are as low as $5 a month for insured patients and $25 for uninsured patients.
Last year, Lilly generated $1.1 billion in revenue from sales of Olumiant. Market projections for alopecia areata are modest, with investment banking firm Mizuho Securities forecasting revenue that could reach $259 million in the US 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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