FDA approves oral JAK inhibitor Leqselvi for severe alopecia areata in adults
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Key takeaways:
- Leqselvi (deuruxolitinib) 8 mg tablet is a twice-daily, oral, selective Janus kinase 1 and 2 inhibitor.
- This is the third systemic medication approved for the treatment of severe alopecia areata in adults.
The FDA has approved Leqselvi 8 mg tablets to treat severe alopecia areata in adults, Sun Pharma announced in a press release.
Of the approximately 700,000 people in the U.S. suffering from alopecia areata, 300,000 of them live with the burden of severe disease. Until recently, treatment options in this indication were limited.
In June 2022, Olumiant (baricitinib, Eli Lilly/Incyte) became the first systemic medication approved for the treatment of severe alopecia areata in adults followed by Litfulo (ritlecitinib, Pfizer) in June 2023, which also extended its treatment population to adolescents for the first time. Now, Leqselvi (deuruxolitinib, Sun Pharma) 8 mg tablets, a twice-daily, oral, selective Janus kinase 1 and 2 inhibitor, is the third systemic medication approved in this indication.
“Leqselvi offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians,” Abhay Gandhi, CEO of North America Business at Sun Pharma, said in the release. “Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.”
The approval was supported by data from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, and two open-label, long-term extension trials.
According to the release, patients only had an average 13% scalp hair coverage at baseline. After 24 weeks of treatment with Leqselvi, more than 30% of patients experienced 80% or more scalp hair coverage, and 25% had nearly 90% or more of their scalp hair return. This trend continued without plateau through 24 weeks.
With safety being a common concern about JAK inhibitor treatments, the data showed that only 3.1% of patients discontinued the trials due to adverse reactions, the most common being headache (12.4% vs. 9.4% with placebo), acne (10% vs. 4.3%) and nasopharyngitis (8.1% vs. 6.7%). The press release noted that more than 100 patients went on to take Leqselvi for more than 3 years.
Perspective
Back to TopThe approval of deuruxolitinib is a three-peat for alopecia areata, marking the third FDA approval for alopecia areata in as many years and will advance our mission to be able to successfully treat everyone with this often devastating condition.
Perspective
Back to TopIt is exciting to have another systemic oral medication approved by the FDA, to keep pushing the ability to regrow hair in most of our patients with alopecia areata. This new JAK inhibitor showed great data on hair regrowth, and expands our treatment armamentarium in our race to grow hair in our patients and maintain the hair regrowth overtime.
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