FDA Approves Deuruxolitinib for the Treatment of Severe Alopecia Areata

The FDA has approved deuruxolitinib (Leqselvi; Sun Pharmaceutical Industries Ltd) 8 mg tablets for the treatment of adults that experience severe alopecia areata. The approval is based on results from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2, that assessed the use of deuruxolitinib among patients with alopecia areata who displayed at least 50% of scalp hair loss.¹

Image credit: Nadya Kolobova | stock.adobe.com

Alopecia areata impacts around 700,000 individuals that reside in the US, with 300,000 of these individuals suffering from severe alopecia areata. The study authors noted that the autoimmune disease occurs due to a breakdown of immune privilege, which results in the immune system targeting hair follicles and causing abrupt hair loss on the scalp, face, and other areas of the body. Individuals with alopecia commonly self-treat before seeking aid from medical professionals due to the lack of steadfast recovery with existing treatment methods.¹

"For many people with severe alopecia areata, early intervention with effective treatment is critical," said Natasha Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology, University of California, Irvine, and investigator in the Leqselvi clinical development program, in a news release. "An oral JAK that delivers proven results will be impactful for the alopecia areata community."¹

The disease can occur in both men, women, and adolescents, impacting up to 2.5% of the U.S and global populations throughout the course of their lives. The FDA has previously approved ritlecitinib (Litfulo; Pfizer Inc) to treat individuals aged 12 years and older with severe alopecia areata— the first FDA approved treatment for adolescents with the disease.² Following, alopecia areata is associated with serious psychological impacts, anxiety, and depression— urging the need for further approved trearments.¹

"We welcome the approval of Leqselvi as a significant step for the alopecia areata community," said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF), in a news release. "Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today's announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata."¹

Deuruxolitinib is a twice-daily oral selective inhibitor of Janus Kinases (JAK), JAK1 and JAK2 that can disrupt the pathways that are linked to the influence of hair loss in severe alopecia areata, according to study authors.¹

The study included 1223 individuals, aged 18-65 years with 50% hair loss caused from alopecia areata, which was measured using the Severity of Alopecia Tool (SALT) which persisted for more than 6 months. The individuals were randomly assigned to receive 8 mg twice daily or 12 mg twice daily of deuruxolitinib or placebo for 24 weeks.¹

The study authors noted that at the trial’s completion, the primary endpoint of a SALT score of 20 or less was met, with more than 30% of individuals treated with deuruxolitinib experienced 80% or more scalp hair coverage. Further results displayed that nearly 25% of individuals had nearly all their scalp hair back at week 24 of the trial.¹

The most common adverse events when being treated with deuruxolitinib included headache, acne, and nasopharyngitis. However, serious adverse effects can include serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities, according to study authors.¹

"Leqselvi offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians," said Abhay Gandhi, CEO, North America Business, Sun Pharma, in a news release. "Our fast-growing dermatology business is excited to add this novel treatment to its portfolio."¹

References

1. U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. PR Newswire. News release. July 26, 2024. Accessed July 29, 2024. https://prnmedia.prnewswire.com/news-releases/us-fda-approves-leqselvi-deuruxolitinib-an-oral-jak-inhibitor-for-the-treatment-of-severe-alopecia-areata-302207625.html.

2. Gallager A. FDA Approves Pfizer’s Ritlecitinib for Treatment of Alopecia Areata in Adolescents. Pharmacy Times. News release. June 26, 2023. Accessed July 29, 2024. https://www.pharmacytimes.com/view/fda-approves-pfizer-s-ritlecitinib-for-treatment-of-alopecia-areata-in-adolescents.