Sun Pharmaceutical Industries Limited recently announced that the U.S. Food and Drug Administration (FDA) has approved LEQSELVI™ (deuruxolitinib) 8 mg tablets for the treatment of severe alopecia areata in adults.
LEQSELVI is a twice-daily oral selective inhibitor of JAK1 and JAK2 and operates by interrupting the pathways that are thought to contribute to hair loss in severe alopecia areata.
Abhay Gandhi, CEO, North America Business, Sun Pharma, has stated, “LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians. Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.”
The approval of LEQSELVI comes after positive results of two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials, THRIVE-AA1 and THRIVE-AA2. These trials involved a total of 1220 patients with alopecia areata who, for more than six months, had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT).
At the study baseline, patients had an average of only 13% scalp hair coverage. By week 24, the primary endpoint of the study was met with over 30% of patients who were taking LEQSELVI experiencing 80% or more scalp hair coverage. In addition, up to 25% of patients had almost all of their scalp hair back at 24 weeks.
During the clinical trials, the most common adverse events reported were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). It is noted that LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. As a result, it should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors.
Natasha A. Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology, University of California, Irvine, and investigator in the LEQSELVI clinical development program notes, “For many people with severe alopecia areata, early intervention with effective treatment is critical. An oral JAK that delivers proven results will be impactful for the alopecia areata community.”
