By: IPP Bureau
Last updated : July 26, 2024 2:15 pm
Leqselvi delivered statistically significant efficacy across two Phase 3 clinical trials
Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (FDA) approved LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.
“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, North America Business, Sun Pharma.
“Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.”
Alopecia areata is a common autoimmune disease in which hair loss is thought to occur due to the collapse of immune privilege, leading to the immune system targeting the hair follicles and causing sudden hair loss on the scalp, face and sometimes other areas of the body.
LEQSELVI is a new, twice daily oral selective inhibitor of Janus Kinases (JAK) JAK1 and JAK2. As a JAK inhibitor, LEQSELVI interrupts the pathways thought to contribute to hair loss in severe alopecia areata.
“We welcome the approval of LEQSELVI as a significant step for the alopecia areata community,” said Nicole Friedland, President and CEO, National Alopecia Areata Foundation (NAAF). “Alopecia areata is an autoimmune disease, with significant physical, emotional and financial impacts that go beyond hair loss. Today’s announcement empowers the alopecia community with even more choices, to which NAAF is committed, and provides another important option for those living with severe alopecia areata.”
The approval is based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which enrolled a total of 1,220 patients with alopecia areata who had at least 50% scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months.
“For many people with severe alopecia areata, early intervention with effective treatment is critical,” said Natasha 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.
“An oral JAK that delivers proven results will be impactful for the alopecia areata community.”
LEQSELVI may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities.
“We are pleased with the timely approval of LEQSELVI by the U.S. FDA,” said Marek Honczarenko, MD, PhD, Senior Vice President, Head of Development, Sun Pharma. “This validates our team’s capability to effectively bring treatments from research and development to approval in a way that is meaningful for physicians and patients. I want to thank all the investigators and patients for their participation in the clinical trials.”