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Alopecia Areata: U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for Severe Cases

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Alopecia Areata, a common autoimmune disease characterized by sudden hair loss on the scalp, face, and other areas of the body, affects around 700,000 people in the United States, with 300,000 experiencing severe cases. This condition often leads patients to self-treat due to dissatisfaction with the slow progress of existing treatments. On July 25, 2024, Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata, offering a new, effective solution for patients and physicians.

LEQSELVI, a twice-daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2, interrupts the pathways believed to contribute to hair loss in severe alopecia areata. By targeting these pathways, LEQSELVI helps in controlling the immune response that leads to hair follicle attack. The approval of this drug is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT).

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Alopecia Areata: NAAF President Nicole Friedland Celebrates LEQSELVI Approval as Significant Advancement in Treatment

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), welcomed the approval, highlighting the significant physical, emotional, and financial impacts of the disease. She emphasized that the new treatment option provided by LEQSELVI empowers the alopecia community with more choices and marks a significant step forward in managing severe alopecia areata.

The THRIVE-AA1 and THRIVE-AA2 trials required participants to have at least 50% scalp hair loss and showed that more than 30% of patients taking LEQSELVI experienced 80% or more scalp hair coverage after 24 weeks. Additionally, up to 25% of patients had almost all of their scalp hair back at 24 weeks. The consistent upward trend in hair regrowth without a plateau during the 24-week trials is a promising indicator of the drug’s effectiveness.

Natasha Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology at the University of California, Irvine, and an investigator in the LEQSELVI clinical development program, stressed the importance of early intervention with effective treatments for people with severe alopecia areata. She noted that an oral JAK inhibitor that delivers proven results will have a significant impact on the alopecia areata community.

Alopecia Areata

Alopecia Areata: LEQSELVI Approval Highlights Promising Results but Warns of Serious Side Effects and Risks

Despite the promising results, LEQSELVI may cause serious side effects, including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. There is also an increased risk of mortality and major cardiovascular events associated with the drug. LEQSELVI should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. In placebo-controlled trials, the most common adverse events were headache, acne, and nasopharyngitis.

Marek Honczarenko, MD, PhD, Senior Vice President, Head of Development at Sun Pharma, expressed satisfaction with the FDA’s timely approval of LEQSELVI. He acknowledged the efforts of the investigators and patients who participated in the clinical trials and emphasized the company’s commitment to supporting the alopecia areata community. Sun Pharma plans to introduce an access program to help eligible patients start and stay on track with their treatment.

LEQSELVI (deuruxolitinib) 8 mg tablets is now an FDA-approved treatment for adults with severe alopecia areata. This autoimmune disease, which affects up to 2.5% of the U.S. and global population, can lead to serious psychological consequences, including anxiety and depression. The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or in conjunction with the scalp. The onset of alopecia areata can occur at any point in life and affects both men and women.

The THRIVE-AA1 and THRIVE-AA2 trials, conducted across the U.S., Canada, and Europe, were pivotal in demonstrating the efficacy of LEQSELVI. Patients in these trials were randomized to receive 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, indicating significant hair regrowth.

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In conclusion, the approval of LEQSELVI by the U.S. FDA marks a significant milestone in the treatment of severe alopecia areata. This new oral JAK inhibitor offers a promising option for patients who have struggled with this challenging condition, providing hope for improved hair regrowth and better quality of life. Sun Pharma’s commitment to the alopecia areata community, coupled with the robust clinical trial data, underscores the potential impact of LEQSELVI in addressing an unmet medical need.

Resource: Sun Pharma, July 26, 2024


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