Sun Pharma Receives US FDA Approval for LEQSELVI™ to Treat Severe Alopecia Areata

Sun Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has granted approval to LEQSELVI™ (deuruxolitinib) for treating adults with severe alopecia areata. This marks a significant development for the estimated 300,000 Americans living with this autoimmune condition characterised by significant hair loss.

Addressing a Growing Need

Alopecia areata is a prevalent condition affecting roughly 700,000 people in the United States. It often leads patients to self-treat due to the limited effectiveness and slow progress of existing therapies. LEQSELVI offers a new option with its twice-daily oral dosage form.

Mechanism of Action

LEQSELVI acts as a selective inhibitor of Janus Kinases (JAK) 1 and 2. By targeting these specific enzymes it aims to disrupt the immune system pathways believed to contribute to severe alopecia areata and subsequent hair loss.

Clinical Trial Results

The FDA approval stems from data gathered in two large-scale clinical trials, THRIVE-AA1 and THRIVE-AA2. These multicenter, randomised, double-blind, placebo-controlled studies included over 1,200 participants with severe alopecia areata.

The primary endpoint at 24 weeks was successfully achieved, with over 30% of patients receiving LEQSELVI experiencing at least 80% scalp hair regrowth, as measured by the Severity of Alopecia Tool (SALT) score. This positive trend continued throughout the trials, with no plateau observed in hair regrowth by week 24. Notably, up to 25% of patients regained nearly all their scalp hair (≥90% coverage) in the same timeframe.

Safety Profile

LEQSELVI demonstrated a favourable safety profile in clinical trials. Across different studies, only a small percentage (3.1%) of patients receiving the 8mg twice-daily dose discontinued treatment due to adverse reactions. Additionally, over 100 participants have been taking LEQSELVI (deuruxolitinib) for more than three years without major safety concerns.

This FDA approval represents a major advancement in the treatment landscape for severe alopecia areata. LEQSELVI offers patients a promising new option with its convenient oral dosage form, encouraging results, and favourable safety profile.

“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 of North America Business, Sun Pharma. “Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.”

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