Sun Pharmaceutical Industries Ltd. has announced that the US Food and Drug Administration (FDA) has approved LEQSELVI (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata.

Alopecia areata affects around 700,000 people in the United States, and 300,000 have severe alopecia areata.

Alopecia often leads patients to self-treat before seeking professional help, driven by dissatisfaction with the slow progress of existing treatments.

"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," Gandhi added.

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 percent scalp hair loss as measured by Severity of Alopecia Tool (SALT) for more than six months. Data were also collected from two open-label, long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials.

At study baseline, the average patient had only 13 percent of their scalp hair coverage. In the trials, at 24 weeks, the primary endpoint was met, with more than 30 percent of patients taking LEQSELVI experiencing 80 percent or more scalp hair coverage (SALT ≤20). The number of patients taking LEQSELVI and achieving a SALT score of ≤20 showed a consistent upward trend with no plateau through 24 weeks. Additionally, up to 25 percent of patients had almost all of their scalp hair back at 24 weeks (≥90 percent coverage). 

"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,” Mesinkovska added.

Across the Phase 2 dose-ranging study and Phase 3 randomized, placebo-controlled trials, a few patients (3.1 percent) receiving LEQSELVI 8 mg twice daily were discontinued from the trials due to adverse reactions. In clinical trials, more than 100 people continued taking deuruxolitinib for more than three years.

"We are pleased with the timely approval of LEQSELVI by the US 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," said Honczarenko.