Sun Pharmaceutical bags LEQSELVI FDA approval for severe alopecia areata

In a significant development for the treatment of severe alopecia areata, Sun Pharmaceutical Industries Limited has announced that the U.S. Food and Drug Administration (FDA) has granted approval for LEQSELVI (deuruxolitinib) 8 mg tablets. This new oral medication, intended for adults suffering from this debilitating autoimmune condition, represents a significant advancement in the management of alopecia areata.

LEQSELVI FDA Approval : A Game-Changer for Severe Alopecia Areata

Alopecia areata, an autoimmune disease affecting approximately 700,000 individuals in the United States, often leads to severe and distressing hair loss. Among these, around 300,000 people suffer from severe forms of the condition. Many patients resort to self-treatment due to dissatisfaction with existing therapies, which are frequently slow to show results.

LEQSELVI, developed by Sun Pharmaceutical, is a selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2, which are believed to play a key role in the pathogenesis of severe alopecia areata. By disrupting these pathways, LEQSELVI aims to halt the progression of hair loss and promote hair regrowth. This twice-daily oral treatment offers a promising new option for those who have struggled with ineffective treatments in the past.

Clinical Trials Highlight LEQSELVI’s Efficacy

LEQSELVI FDA approval is based on robust data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. These trials involved 1,220 patients who had experienced at least 50% scalp hair loss for over six months. Results showed that, after 24 weeks of treatment, more than 30% of patients achieved 80% or more scalp hair coverage, as measured by the Severity of Alopecia Tool (SALT). Notably, up to 25% of patients had nearly complete regrowth (≥90% coverage) by the end of the study period.

Dr. Natasha Mesinkovska, an Associate Professor and Vice Chair for Clinical Research of Dermatology at the University of California, Irvine, and an investigator in the LEQSELVI clinical programme, emphasised the significance of this oral JAK inhibitor. According to Dr. Mesinkovska, early and effective intervention is crucial for many patients with severe alopecia areata, and LEQSELVI’s proven results could have a substantial impact on the community.

Safety Profile and Considerations

Despite its promising efficacy, LEQSELVI is not without potential risks. Clinical trials indicated that the most common adverse effects included headache, acne, and nasopharyngitis, with a small percentage of patients (3.1%) discontinuing the treatment due to adverse reactions. The medication may also pose risks of serious side effects such as infections, malignancies, thrombosis, and gastrointestinal issues. It is contraindicated in patients who are poor metabolizers of CYP2C9 or who are using strong CYP2C9 inhibitors.

Expert and Community Reactions on LEQSELVI FDA Approval

Abhay Gandhi, CEO of North America Business at Sun Pharmaceutical, expressed enthusiasm about the approval, noting that LEQSELVI will enhance treatment options for patients and their healthcare providers. Similarly, Nicole Friedland, President and CEO of the National Alopecia Areata Foundation (NAAF), highlighted the approval as a significant milestone for the alopecia areata community. Friedland underscored the importance of providing patients with more choices to manage the physical, emotional, and financial challenges associated with this condition.

Marek Honczarenko, MD, PhD, Senior Vice President and Head of Development at Sun Pharmaceutical, also praised the FDA’s decision, recognising the approval as a testament to the company’s commitment to advancing treatments from research through to patient benefit.

A New Era for Alopecia Areata Treatment

LEQSELVI FDA approval marks a major advancement in the treatment landscape for severe alopecia areata. As an oral JAK inhibitor, LEQSELVI offers a novel approach to managing this challenging autoimmune disease, providing new hope for patients who have long awaited an effective treatment option.