Sun Pharma's Leqselvi (Deuruxolitinib) Approved by FDA for Severe Alopecia Areata, Demonstrating Over 80% Scalp Hair Regrowth in Clinical Trials

July 25,Indian pharmaceutical company Sun Pharmaceuticals (hereinafter referred to as “Sun Pharma”) announced that the FDA has approved Leqselvi (deuruxolitinib) 8 mg tablets for the treatment of severe alopecia areata in adults。

The FDA’s approval was primarily based on positive data from two Phase 3 studies of Leqselvi. Clinical study results showed that,Following treatment with Leqselvi, one-third of patients achieved 80% scalp hair coverage, and one-quarter of patients achieved over 90% scalp hair coverage.。

Sun Pharma is a multinational pharmaceutical company headquartered in Mumbai, India, primarily engaged in the production and sales of various pharmaceutical formulations and active pharmaceutical ingredients (APIs) in India and the United States. Founded in 1983, the company acquired Ranbaxy in 2014, thereby becoming India’s largest pharmaceutical company. Currently, Sun Pharma operates ten R&D centers and 43 manufacturing facilities worldwide. Its business portfolio spans innovative specialty drugs, generic medicines, and APIs, with a focus on therapeutic areas including dermatology, neurology, cardiology and cerebrovascular diseases, oncology, and ophthalmology. The company exports its products to more than 100 countries and regions globally.

This approvalLeqselvi is an oral selective JAK1/JAK2 inhibitor., previously developed by the clinical-stage biotechnology company Concert Pharmaceuticals. In March 2023, Sun Pharma acquired Concert Pharmaceuticals for $576 million, obtaining all rights to Leqselvi.

The approval of Leqselvi was based on data from two multicenter, randomized, double-blind, placebo-controlled Phase 3 clinical trials—THRIVE-AA1 and THRIVE-AA2. These trials enrolled 706 and 517 patients aged 18–65 years with moderate-to-severe alopecia areata, respectively. As measured by the Severity of Alopecia Tool (SALT), these patients had experienced at least 50% hair loss and had been suffering from hair loss for more than six months.

Patients in the trial group are required to receive Leqselvi at a dose of 8 mg or 12 mg twice daily. The primary endpoint of the study is the proportion of patients achieving a SALT score of ≤20 (i.e., scalp hair coverage ≥80%) at Week 24. Additionally, Sun Pharma has collected data from two open-label long-term extension trials, in which patients could enroll after completing the 24-week trial. Existing clinical data have demonstrated that Leqselvi exhibits favorable efficacy and safety profiles.

At baseline, the patient’s scalp hair coverage was only 13%. At Week 24, the clinical trial met its primary endpoint.Following treatment with Leqselvi, over 30% of patients achieved a scalp hair coverage of 80% (SALT ≤20), with the number of such patients showing a sustained upward trend at 24 weeks without plateauing. Importantly, by Week 24, 25% of patients experienced near-complete hair regrowth, with hair coverage ≥90%.。

In the THRIVE-AA1 study, patients had a baseline SALT score of 85.9. The results showed that the proportions of patients achieving a SALT score ≤20 were 29.6% and 41.5% in the 8 mg and 12 mg dose groups, respectively, compared with only 0.8% in the placebo group.

In the THRIVE-AA2 study, patients had a baseline SALT score of 87.9. The results showed that the proportions of patients achieving a SALT score ≤20 were 33.0% and 38.3% in the 8 mg and 12 mg dose groups, respectively, compared with only 0.8% in the placebo group.

Furthermore, in the Phase 2 dose-ranging study and the Phase 3 randomized placebo-controlled trial, only 3.1% of patients discontinued the trial due to adverse reactions after taking 8 mg of Leqselvi twice daily. In clinical trials, more than 100 patients have been treated with Leqselvi for over three years.

Alopecia areata is a common autoimmune disorder and the second most prevalent form of hair loss, following androgenetic alopecia. It results in partial or complete hair loss on the scalp, face, or other parts of the body due to immune system attacks on hair follicles. The pathogenesis of alopecia areata remains unclear; it is generally believed to arise from the interplay between genetic and environmental factors, with potential etiologies including genetic predisposition, nonspecific stimuli, and psychological factors.

Alopecia areata typically onsets between the ages of 25 and 35; however, individuals of any age, gender, or ethnicity may be affected. The scalp is generally the most commonly and severely involved site. Although alopecia areata is not a life-threatening condition, many patients experience significant psychological distress, which adversely affects their mental health and quality of life.

According to incomplete statistics, there are approximately 147 million alopecia areata patients worldwide.. Among them, there are approximately 4 million patients in China, and the incidence rate among children and adolescents accounts for as high as 12.8% of the total number of alopecia areata patients. A survey across six provinces in China showed that the prevalence of alopecia areata in China is 0.27%, with nearly 18.1% of alopecia areata patients diagnosed before the age of 18.

In the United States, mild-to-moderate alopecia areata (hair loss <50%/SALT score <50) accounts for more than half of the 800,000 patients with alopecia areata. Furthermore, according to a study published in JAMA Dermatology, the prevalence and incidence of alopecia areata among individuals aged 12–17 years in the United States increased between 2016 and 2019, peaking in early adulthood (ages 18–44).

According to Market Data Forecast, the global hair loss market size reached USD 8.81 billion in 2021 and is projected to grow to USD 13.44 billion (approximately RMB 89.6 billion) by 2026, with a compound annual growth rate (CAGR) of 8.8%. In response to this multi-billion-dollar market, pharmaceutical companies both domestically and internationally are entering the field to develop innovative therapies for alopecia areata.

In June 2022, the FDA announced its approval of baricitinib (brand name Olumiant), an oral JAK inhibitor jointly developed by Eli Lilly and Incyte, for the treatment of adult patients with severe alopecia areata. According to the press release, this is the first systemic therapy approved by the FDA for the treatment of alopecia areata.

The following year, the FDA approved Pfizer’s dual kinase inhibitor Litfulo (ritlecitinib) for the treatment of patients aged 12 years and older with severe alopecia areata. Notably, this marks the first FDA approval of a therapeutic agent for adolescents (aged 12 and above) with severe alopecia areata.

In 2023, JAK inhibitor analogs from Pfizer and Eli Lilly were approved for marketing in China for the treatment of alopecia areata. Currently, no domestically produced JAK inhibitors have been approved for the treatment of alopecia areata. However, Chinese pharmaceutical companies such as Hengrui Medicine, Zeltis Pharma, Kelun Pharmaceutical, and Qiyuan Bio have laid out clinical pipelines for alopecia areata candidate therapies, with some products already in Phase II and Phase III clinical trials. Recently, domestic enterprises have also made new progress in the research and development of therapeutic drugs for alopecia areata.

June 12, 2024Zelgen Biopharmaceuticals announced that the pivotal Phase 3 clinical trial of its independently developed gacitinib hydrochloride tablets (formerly known as jaketinib hydrochloride tablets) for the treatment of severe alopecia areata met the primary efficacy endpoint, achieving statistical significance (p<0.0001).. Zeltex Pharmaceuticals stated that the company will accelerate the market launch process for the indication of ruxolitinib hydrochloride tablets in treating patients with severe alopecia areata.