Leqselvi shows significant effectiveness in two Phase 3 clinical trials. Initially, patients had only 13% scalp hair coverage, but after 24 weeks, one-third achieved 80% coverage.
Sun Pharmaceutical Industries Limited has announced that the U.S. Food and Drug Administration (FDA) has approved Leqselvi (deuruxolitinib) 8 mg tablets for adult patients suffering from severe alopecia areata.
Alopecia areata affects around 700,000 individuals in the U.S., with 300,000 experiencing severe symptoms. Many patients self-treat due to dissatisfaction with the slow progress of existing therapies.
Alopecia areata is a prevalent autoimmune disorder causing hair loss due to the immune system attacking hair follicles. Leqselvi, a twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2, disrupts pathways involved in hair loss in severe cases of this condition.
The approval of Leqselvi is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, involving 1,220 patients with at least 50% scalp hair loss measured by the Severity of Alopecia Tool (SALT) for more than six months. Patients also participated in two open-label, long-term extension trials after completing the 24-week studies. Initially, patients had an average of 13% scalp hair coverage. At 24 weeks, over 30% of patients on LEQSELVI achieved 80% or more scalp hair coverage (SALT ≤20), with up to 25% regaining almost all their scalp hair (≥90% coverage).
In clinical trials, a small percentage of patients (3.1%) discontinued Leqselvi due to adverse reactions. More than 100 participants have continued treatment with deuruxolitinib for over three years. However, Leqselvi may cause serious side effects, including infections, malignancies, thrombosis, gastrointestinal perforations, and certain lab abnormalities. It should not be used in patients who are CYP2C9 poor metabolizers or are taking moderate or strong CYP2C9 inhibitors. The most common side effects in placebo-controlled trials included headaches, acne, and nasopharyngitis.
Sun Pharma is dedicated to supporting the alopecia areata community and will introduce an access program to help eligible patients begin and maintain their treatment.
About the THRIVE-AA1 and THRIVE-AA2 Trial Design
THRIVE-AA1 and THRIVE-AA2 were randomized, double-blind, placebo-controlled clinical trials involving 1,223 adults aged 18-65 with severe alopecia areata. Conducted at sites in the U.S., Canada, and Europe, the trials evaluated scalp hair regrowth over 24 weeks using the SALT score. Participants were given either 8 mg or 12 mg of deuruxolitinib twice daily or a placebo. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. Enrollees were required to have at least 50% scalp hair loss due to alopecia areata, with baseline SALT scores averaging around 85.9 and 87.9 in the respective trials.
About Leqselvi and Alopecia Areata
Leqselvi(deuruxolitinib) 8 mg tablets are an oral selective inhibitor of Janus kinases JAK1 and JAK2, approved for treating adults with severe alopecia areata. This autoimmune disorder results in partial or complete hair loss on the scalp and body. Alopecia areata can affect up to 2.5% of the population in the U.S. and globally during their lifetime. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or in combination with the scalp. The disease can begin at any age and affects both men and women, often leading to psychological issues such as anxiety and depression.
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