This past July, the U.S. Food and Drug Administration (FDA) approved LEQSELVI™ (deuruxolitinib) for alopecia areata, making it the third FDA-approved treatment for adults living with severe disease. However, this approval has resulted in a legal dispute between Sun Pharmaceutical Industries, Ltd., LEQSELVI’s manufacturer, and Incyte Corporation, the patent holder for a similar drug, ruxolitinib. On November 1, the court ruled in favor of Incyte, resulting in an injunction that blocks the commercial release of LEQSELVI. With the court ruling in Incyte’s favor, Sun Pharma faces an indefinite delay in launching LEQSELVI unless it wins an appeal or waits until the ruxolitinib patent expires in December 2026. Sun Pharma has announced plans to appeal, though the process could take months, and the outcome remains uncertain. For those living with alopecia areata, LEQSELVI’s availability as a treatment option remains in question, as does the status of the ongoing long-term extension trial for the drug that includes hundreds of individuals currently on LEQSELVI. Two other FDA-approved treatments for severe disease are already on the market: Lilly’s Olumiant™ (baricitinib) for adults and Pfizer’s LITFULO™ (ritlecitinib) for individuals 12 and older. In communications with NAAF, Sun Pharma expressed continued commitment to the alopecia areata community. NAAF will continue to post key information updates as they become available.
