FDA Approves Sun Pharma’s Leqselvi for Treating Adults with Severe Alopecia Areata

Image Credit: Adobe Stock Images/Berit Kessler

The FDA has approved Sun Pharma’s Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of adults with severe alopecia areata. The novel, oral Janus kinase (JAK) inhibitor targets the JAK1 and JAK2 pathways, which are both believed to be catalysts for the autoimmune response that leads to hair loss. The approval, which was based on positive data from the Phase III THRIVE-AA1 and THRIVE-AA2 trials, demonstrated the efficacy of Leqselvi in treating alopecia areata.¹

“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, in a press release. “Our fast-growing dermatology business is excited to add this novel treatment to its portfolio.”

THRIVE-AA1 and THRIVE-AA2 were randomized, double-blind, placebo-controlled trials that included 1223 adult patients ages 18-65 years with severe alopecia areata at clinical sites in the United States, Canada, and Europe. Investigators evaluated the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score. Per the trial, patients were randomly assigned to receive either Leqselvi 8 mg twice daily, Leqselvi 12 mg twice daily, or placebo for 24 weeks. The primary endpoint of the studies was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. In order to qualify for the trials, patients were required to have at least 50% scalp hair loss due to alopecia areata.

Results found that at 24 weeks, over 30% of patients achieved substantial hair regrowth up to at least 80%. Additionally, up to 25% regained mostly complete scalp coverage after 24 weeks of treatment. At baseline, the average patient had only 13% of their scalp hair coverage. Lastly, the number of patients taking Leqselvi and achieving a SALT score of ≤20 showed a consistent upward trend with no plateau through 24 weeks.

The most common adverse events reported during the trials included headache, acne, and nasopharyngitis. Sun Pharma warns that taking Leqselvi also may cause serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. The treatment is not recommended for patients who are CYP2CP poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors.¹

“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.”

Alopecia areata can affect any hair-bearing area, including multiple areas simultaneously. It effects the scalp anywhere from 66.8% to 95% of the time, the beard for 28% of male patients, 3/8% in eyebrows, and 1.3% in extremities. In approximately 80% of all cases, it on affects a single patch, while two or more patches can also be affected less commonly.²

“We welcome the approval of Leqselvi as a significant step for the alopecia areata community,” said Nicole Friedland, president, CEO, National Alopecia Areata Foundation (NAAF), in the press release. “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.”

References

1. U.S. FDA Approves LEQSELVI™ (deuruxolitinib), an Oral JAK Inhibitor for the Treatment of Severe Alopecia Areata. Sun Pharma. July 25, 2024. Accessed July 29, 2024. https://sunpharma.com/wp-content/uploads/2024/07/Sunpharma-LEQSELVI-Approval-Scenario-Press-Release.pdf

2. Alopecia Areata. Medscape. June 27, 2023. Accessed July 29, 2024. https://emedicine.medscape.com/article/1069931-overview?form=fpf