FDA Approves Deuruxolitinib for Alopecia Areata

The U.S. Food and Drug Administration (FDA) has approved deuruxolitinib 8-mg tablets for the treatment of adults with severe alopecia areata, Sun Pharmaceuticals Industries Limited announced in a press release.

Deuroxolitinib is available from Sun Pharma under the name LEQSELVI.

"LEQSELVI offers a new and effective solution that will significantly enhance options for long-suffering patients battling severe alopecia areata and their physicians," Abhay Gandhi, CEO, North America Business for Sun Pharma, said in the press release. "Our fast-growing dermatology business is excited to add this novel treatment to its portfolio."

LEQSELVI is a 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 of the 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. 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% of their scalp hair coverage. In the trials, at 24 weeks, the primary endpoint was met, with more than 30% of patients taking LEQSELVI experiencing 80% 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% of patients had almost all of their scalp hair back at 24 weeks (≥90% coverage).

"For many people with severe alopecia areata, early intervention with effective treatment is critical," said Practical Dermatology Editorial Board member Natasha Mesinkovska, MD, PhD, Associate Professor and Vice Chair for Clinical Research of Dermatology at the 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."