Sun Pharma receives US FDA approval for drug to treat alopecia areata

Autoimmune disorder characterised by hair loss affects some 700,000 people in the US

Sun Pharmaceutical Industries has received US Food and Drug Administration (FDA) approval for LEQSELVI (deuruxolitinib) that is used for treating an autoimmune disorder in adults.

Alopecia areata, which is characterised by hair loss, affects some 700,000 people in the United States, with 300,000 experiencing severe forms of the condition. Current treatments have shown slow progress, prompting some 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.

"This new treatment option empowers the alopecia community with more choices and provides an important option for those living with severe alopecia areata," said Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation (NAAF) in the US.

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 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 Dr Natasha Mesinkovska, 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."

Dr Marek Honczarenko, 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 a 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.