Sun Pharma announced that the US FDA approved LEQSELVI (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata. (1)

Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe alopecia areata. (2,3) Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments. (4,5) 

Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body. (4,5)  LEQSELVI is a new, twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata. (1)

The approval is based on data from two multicentre, randomised, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50 per cent scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months, data were also collected from two open-label, long-term extension trials in which patients were eligible to enrol upon completion of the 24-week trials.

At study baseline, the average patient had only 13 per cent of their scalp hair coverage. In the trials, at 24 weeks, the primary endpoint was met, with more than 30 per cent of patients taking LEQSELVI experiencing 80 per cent or more scalp hair coverage (SALT ≤20). (1) The number of patients taking LEQSELVI and achieving a SALT score of ≤20 showed a consistent upward trend with no plateau through 24 weeks. (1)  Additionally, up to 25 per cent of patients had almost all of their scalp hair back at 24 weeks (≥90 per cent coverage). (1) 

Across the Phase 2 dose-ranging study and Phase 3 randomised, placebo-controlled trials, a few patients (3.1 per cent) receiving LEQSELVI 8 mg twice daily were discontinued from the trials due to adverse reactions. (1)  In clinical trials, more than 100 people continued taking deuruxolitinib for more than three years. (1)  

References 

1. LEQSELVI Prescribing Information. LEQSELVI U.S. Product Information. July 2024. Princeton, N.J.: Sun Pharmaceutical Industries Limited.

2. National Alopecia Areata Foundation. National Alopecia Areata Foundation. https://www.naaf.org/.

3. Benigno M. A Large Cross-Sectional Survey Study of the Prevalence of alopecia areata in the United States, Clinical, Cosmetic and Investigational Dermatology 2020.

4. Pratt H et al. Alopecia areata. Nat Rev Dis Primers. 2017; 3: 17011.

5. King B et al. Overview of alopecia areata for managed care and payer stakeholders in the United States. J Manag Care Spec Pharm. 2023; 29(7): 848-856.