Leqselvi Can Achieve Nearly 90% Scalp Hair Coverage in Severe Alopecia Areata Patients

The US Food and Drug Administration (FDA) has just approved Leqselvi (deuruxolitinib), a new oral medication by Sun Pharmaceutical Industries Limited, offering significant hope for those suffering from severe alopecia areata, a condition causing sudden hair loss.

This approval marks a significant milestone, bringing new possibilities to the estimated 300,000 people in the US who deal with severe forms of this autoimmune disease. Leqselvi is the second oral drug approved for severe alopecia areata after Pfizer’s Litfulo (ritlecitinib) last year.

Related: Pfizer’s Newly Approved Litfulo to Take on Eli Lilly’s Olumiant in Growing Alopecia Market

So, what is alopecia areata? Alopecia areata occurs when the immune system mistakenly attacks hair follicles, leading to hair loss on the scalp, face and sometimes other body parts. It leads to partial or complete hair loss on the scalp and other body parts, with patterns varying from patchy bald spots to total scalp or body hair loss. Alopecia areata can be triggered by genetics, immune system dysfunction and environmental factors.

Leqselvi works by selectively inhibiting the Janus kinases (JAK) JAK1 and JAK2, pathways that play a key role in this misguided immune response.

Leqselvi’s approval is based on data from two Phase III clinical trials, THRIVE-AA1 and THRIVE-AA2, which together enrolled over 1,200 patients. At the start of the study, participants had an average of just 13 percent scalp hair coverage. After 24 weeks of treatment with deuruxolitinib, over 30 percent of patients experienced significant hair regrowth, achieving at least 80 percent scalp hair coverage. Impressively, up to 25 percent of patients saw their hair coverage reach 90 percent or more.

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Leqselvi Is a New Option for Patients

This development is particularly exciting for patients who have been frustrated with the limited treatment options available. “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 of Sun Pharma’s North America Business, in the news release.

Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF), also emphasized the importance of this approval, noting the significant physical, emotional and financial impacts of alopecia areata.

Alopecia areata care goes beyond hair growth, and patients are often burdened with high anxiety and depression. With Leqselvi, patients have fresh hope for regaining their hair and confidence. Celebrities such as Ashley Tisdale, who recently shared her journey with severe alopecia areata with Pfizer, are among many who have opened up about their struggles of living with and managing this autoimmune disease.

“An oral JAK that delivers proven results will be impactful for the alopecia areata community,” added Dr. Natasha Mesinkovska, associate professor and vice chair for Clinical Research of Dermatology, University of California, Irvine and investigator in the Leqselvi clinical development program.

Leqselvi can cause serious side effects, including infections, cancer, blood clots and stomach issues, and should not be used by certain patients who metabolize CYP2CP poorly or those taking CYP2C9 inhibitors.