New Alopecia Drug Offers Fast Hair Regrowth

Sun Pharma has made available the new oral treatment, Leqselvi (deuruxolitinib), for severe alopecia areata today in the United States, offering another alternative to patients living with this autoimmune hair loss condition.

The new drug offered in 8 mg tablets, is approved for adults with severe alopecia areata, a disease that causes the immune system to attack hair follicles, leading to partial or complete hair loss on the scalp and body. Up to 2.5% of people in the U.S. may be affected by the condition at some point in their lives, according to Sun Pharma.

The clinical trial data supporting Leqselvi shows how quickly the drug can help restore hair for many patients.

Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, resulting in partial or complete loss of hair on the scalp and body. © Nadya Kolobova - stock.adobe.com

Leqselvi is a Janus kinase (JAK) inhibitor that works by targeting immune pathways involved in inflammation.

In clinical trials, the drug demonstrated fast and significant hair regrowth for many patients. It was found that at 24 weeks, more than 30% of patients experienced 80% or more scalp hair coverage, and up to 25% had nearly full regrowth (≥90% coverage). At the beginning of treatment, patients had, on average, just 13% of their scalp hair remaining.

Arash Mostaghimi, M.D., MPA, MPH, vice chair of clinical trials and innovation at Brigham & Women's Hospital Department of Dermatology, said based on the “compelling” results of the clinical trials, Leqselvi will provide “clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”

The approval was based on the THRIVE-AA1 and THRIVE-AA2 trials, which included more than 1,200 adult patients across the U.S., Canada and Europe.

Participants in the studies were randomized to receive either 8 mg or 12 mg of Leqselvi twice daily or a placebo. The primary goal was to reduce the Severity of Alopecia Tool (SALT) score to 20 or less at 24 weeks.

A SALT score of 100 indicates total scalp hair loss, while 0 indicates full coverage.

The drug’s speed and visible results address a key concern for patients living with alopecia areata.

The physical effects of alopecia areata are often accompanied by psychological distress, including anxiety and reduced self-confidence. The condition’s unpredictability makes it especially difficult for patients, who often report a desire for fast-acting treatment.

In a news release, Sun Pharma shared that 83% of patients prefer treatment options that deliver rapid results.

Although the drug company did not disclose the wholesale acquisition cost of Leqselvi, the company did express efforts to make the medication accessible through collaboration with insurers.

A company spokesperson told Managed Healthcare Executive they developed another initiative to help patients with affordability challenges through the Leqselvi SUPPORT program.

The program offers eligible patients their medication for as little as $0 for up to two years. SUPPORT includes access to a dedicated patient access liaison, who provides personalized assistance throughout the treatment process.

Like many immune-targeting therapies, Leqselvi carries safety risks that patients and doctors must consider.

In clinical trials, the most common side effects were headache (12.4%), acne (10%) and nasopharyngitis (8.1%), compared to lower rates among those taking placebo.

With the launch just beginning, Sun Pharma currently has only clinical trial data to draw from, though real-world evidence could come later, the spokesperson shared.

As of now, the drug’s launch highlights a shift in the treatment landscape for severe alopecia areata and offers new hope for patients seeking rapid and visible improvement.