Sun Pharmaceutical Industries Limited announced the official launch of LEQSELVI™ (deuruxolitinib tablets 8 mg) in the United States for the treatment of adults with severe alopecia areata. The milestone comes after Sun Pharma reached a patent settlement with Incyte Corporation, clearing the way for commercial rollout.
In a separate release, the company confirmed it had resolved its ongoing patent litigation with Incyte in the United States District Court for the District of New Jersey. As part of the agreement, Incyte granted Sun Pharma a limited, non-exclusive license to several U.S. patents, allowing Sun to commercialize deuruxolitinib for non-oncology, non-hematology indications, including alopecia areata. The litigation between both parties has been dismissed, with mutually agreed financial terms, including an upfront payment and future royalties.
Following this legal clarity, Sun has launched LEQSELVI across the U.S. market. The drug is indicated for adults suffering from severe alopecia areata, a chronic autoimmune condition that leads to patchy or complete hair loss. The company highlights that LEQSELVI offers a convenient, once-daily oral treatment option.
“The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them,” said Richard Ascroft, CEO, Sun Pharma North America. “As a company committed to launching new therapeutic options which address the unmet needs of patients, adding LEQSELVI to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community.”
With limited treatment options available to people living with severe alopecia areata in the U.S., the need for innovative therapies such as LEQSELVI remains critically important. LEQSELVI demonstrated rapid results in clinical trials with one third of patients regaining almost all of their hair by Week 24. Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks.
“The clinical evidence for LEQSELVI is truly compelling, demonstrating consistent efficacy," said Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women's Hospital. "LEQSELVI provides clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”
