Sun Pharma receives US FDA approval for drug to treat alopecia areata
Sun Pharma stock was up 2.2 per cent in morning trade on BSE.
Sun Pharmaceutical Industries, a global leader in specialty generics, has received U.S. Food and Drug Administration (FDA) approval for LEQSELVI (deuruxolitinib) for the treatment of severe alopecia areata in adults.
Sun Pharma stock was up 2.2 per cent in morning trade on BSE.
Alopecia areata, an autoimmune disorder characterised by hair loss, affects approximately 700,000 individuals in the United States, with 300,000 experiencing severe forms of the condition. Current treatments for alopecia areata have shown slow progress, often leading patients to seek alternative solutions.
LEQSELVI is a new, twice-daily oral Janus Kinase (JAK) inhibitor that disrupts the pathways involved in hair loss. In two Phase-III clinical trials, patients initially had an average of only 13 per cent scalp hair coverage. After 24 weeks of treatment, one-third of the patients achieved 80 per cent scalp hair coverage.
“LEQSELVI represents a significant advancement for patients with severe alopecia areata,” said Abhay Gandhi, chief executive officer of North America Business at Sun Pharma. “Our growing dermatology portfolio is excited to include this innovative treatment.”
Alopecia areata occurs when the immune system targets hair follicles, causing sudden hair loss on the scalp, face, and other parts of the body. LEQSELVI, a twice-daily oral selective inhibitor of Janus Kinases (JAK1 and JAK2), works by interrupting the pathways believed to contribute to hair loss in severe alopecia areata.
Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation (NAAF), welcomed the approval, stating, “This new treatment option empowers the alopecia community with more choices and provides an important option for those living with severe alopecia areata.”
The approval was based on data from the THRIVE-AA1 and THRIVE-AA2 trials, which involved 1,220 patients with at least 50 per cent scalp hair loss. The primary endpoint, achieving a SALT (Severity of Alopecia Tool) score of 20 or less at 24 weeks, was met, with more than 30 per cent of patients achieving 80 per cent or more scalp hair coverage. Additionally, up to 25 per cent of patients experienced almost complete scalp hair regrowth (90 per cent coverage) at 24 weeks.
During the clinical trials, 3.1 per cent of patients discontinued treatment due to adverse reactions. LEQSELVI may cause serious side effects, including infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. Common adverse events included headache, acne, and nasopharyngitis.
“Early intervention with an effective treatment is critical for those with severe alopecia areata,” said Natasha Mesinkovska, MD, PhD, associate professor at the University of California, Irvine, and an investigator in the LEQSELVI clinical development programme. “LEQSELVI offers proven results and will be impactful for the alopecia areata community.”
Marek Honczarenko, MD, PhD, senior vice president and head of development at Sun Pharma, expressed satisfaction with the FDA’s timely approval. “This approval validates our team’s capability to bring treatments from research and development to approval in a meaningful way for physicians and patients,” he said.
Sun Pharma is the world’s leading specialty generics company, offering a range of specialty, generics, and consumer healthcare products. It is the largest pharmaceutical company in India and a leading generic company in the United States and global emerging markets. Sun Pharma’s high-growth global specialty portfolio includes products in dermatology, ophthalmology, and onco-dermatology.
First Published: Jul 26 2024 | 11:28 AM IST