FDA Approves LEQSELVI™ for Severe Alopecia Areata

Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for treating adults with severe alopecia areata. Alopecia areata is an autoimmune disease that causes sudden hair loss on the scalp, face, and sometimes other parts of the body. In the U.S., about 700,000 people suffer from this condition, with 300,000 experiencing severe forms.

LEQSELVI is a Janus Kinase (JAK) inhibitor, specifically targeting JAK1 and JAK2, to disrupt pathways responsible for hair loss in severe alopecia areata. Abhay Gandhi, CEO of North America Business at Sun Pharma, emphasized that LEQSELVI offers a novel solution for patients and physicians dealing with this challenging condition.

The approval came on the basis of data from two pivotal Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. These randomized, double-blind, placebo-controlled trials involved 1,220 patients with at least 50% scalp hair loss. The trials aimed to assess the regrowth of scalp hair over 24 weeks using the Severity of Alopecia Tool (SALT) score. At the start of the study, the average patient had only 13% scalp hair coverage. By week 24, over 30% of patients taking LEQSELVI achieved 80% or more scalp hair coverage. Furthermore, up to 25% of patients had regained almost all of their scalp hair (≥90% coverage) after 24 weeks.

Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), welcomed the approval, noting its importance to the alopecia areata community. She highlighted the significant physical, emotional, and financial impacts of the disease beyond hair loss.

Dr. Natasha Mesinkovska, 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 treatment for those with severe alopecia areata. The clinical data indicated a consistent upward trend in hair regrowth among patients taking LEQSELVI without a plateau through 24 weeks.

Adverse reactions led to the discontinuation of 3.1% of patients in the clinical trials. More than 100 people continued taking deuruxolitinib for over three years. However, LEQSELVI may cause serious side effects, including infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. The most common adverse events reported 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, attributing it to the team's effective research and development capabilities. He also acknowledged the contributions of investigators and patients in the clinical trials.

Sun Pharma plans to introduce an access program to support eligible patients in starting and continuing their treatment with LEQSELVI. Alopecia areata affects up to 2.5% of the population in the U.S. and globally. The condition can lead to serious psychological consequences, such as anxiety and depression. There are currently limited approved treatments for this autoimmune disease, making the approval of LEQSELVI a significant advancement for patients seeking effective solutions.

The THRIVE-AA1 and THRIVE-AA2 clinical trials were conducted across various sites in the U.S., Canada, and Europe, involving 1,223 adult patients. The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. The average baseline SALT score was approximately 85.9 in THRIVE-AA1 and 87.9 in THRIVE-AA2, indicating severe scalp hair loss among participants.

Overall, LEQSELVI's approval represents a meaningful development for the treatment of severe alopecia areata, providing new hope for patients and healthcare providers.