Leqselvi is an oral drug that selectively inhibits Janus kinases JAK1 and JAK2. It has been approved for adult patients experiencing severe forms of alopecia areata, an autoimmune disease where hair follicles come under attack from one’s immune system, causing varying degrees of hair loss on both scalp and body.
Sun Pharma North America CEO Richard Ascroft said: “The launch of LEQSELVI in the U.S. brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them.
“As a company committed to launching new therapeutic options which address the unmet needs of patients, adding LEQSELVI to our dermatology portfolio represents a key milestone for the business and an important advancement for the alopecia areata community.”
Clinical trials have shown promising results; approximately one-third of participants treated with Leqselvi saw substantial hair regrowth by Week 24. Notably, some patients (3%) achieved more than 80% scalp coverage as early as eight weeks into their treatment regimen.
The efficacy of deuruxolitinib was evaluated through two pivotal studies—THRIVE-AA1 and THRIVE-AA2, which were randomised, double-blind, placebo-controlled clinical trials involving 1,223 adult patients between the ages of 18-65 suffering from severe alopecia areata.
Subjects received either twice daily 8mg or 12mg doses of deuruxolitinib or a placebo.
For 24 weeks, Severity of Alopecia Tool (SALT) score was used to measure outcomes related to scalp hair regrowth.
The primary endpoint was to determine the percentage of patients achieving a SALT score equal to or less than 20 at 24 weeks.
Participants involved were required to have experienced at least 50% scalp hair loss due to their condition before entering these trials, with a SALT score ranging from zero (no loss) up to 100 (complete loss).
Across the THRIVE-AA1 and THRIVE-AA2 studies’ cohorts, average baseline SALT scores were approximately 85.9 and 87.9, respectively.
National Alopecia Areata Foundation (NAAF) president and CEO Nicole Friedland said: “The availability of LEQSELVI offers hope to our community, delivering a new, effective treatment option for adults living with severe alopecia areata.
“NAAF is thrilled to see expanded choices and increased opportunities for individuals to find an FDA-approved treatment to address hair loss caused by this autoimmune disease.”
The psychological impact of severe alopecia areata is profound, often leading to distress and loss of self-confidence among sufferers.