• 15 Jul 2025
• Admin
• News Article

Sun Pharma launches Leqselvi in US for treatment of severe alopecia areata

Overview

Sun Pharmaceutical Industries Limited announced Leqselvi (deuruxolitinib) 8 mg tablets is now available to healthcare providers and people living with severe alopecia areata in the US. Leqselvi is indicated for the treatment of adults with severe alopecia areata.

Statement from Richard Ascroft, CEO, Sun Pharma North America

“The launch of Leqselvi in the US brings an effective, new treatment option for severe alopecia areata to eligible patients and the healthcare providers who treat them,” said Richard Ascroft, CEO, Sun Pharma North America. “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.”

Leqselvi Shows Rapid Results in Severe Alopecia Areata

With limited treatment options available to people living with severe alopecia areata in the US, the need for innovative therapies such as Leqselvi remains critically important. Leqselvi demonstrated rapid results in clinical trials with one third of patients regaining almost all of their hair by Week 24. Some patients (3%) achieved 80% or more scalp coverage as fast as 8 weeks.

Words from Assistant professor: Arash Mostaghimi

“The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy,"" said Arash Mostaghimi, MD, MPA, MPH, FAAD, vice chair of clinical trials and innovation and Associate Professor of Dermatology at Brigham and Women's Hospital. "" Leqselvi provides clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”

Psychosocial challenges by alopecia areata

• The psychosocial impact of alopecia areata can be significant. 
• Many people living with severe alopecia areata face psychological distress, including loss of self-confidence, due to the unpredictable nature of hair loss, underscoring the importance of effective treatment solutions. 
• A medication that works fast is critical for alopecia areata patients. 
• In a recent survey, 83% of patients preferred a treatment with attributes that included speed. Fast regrowth brings back more than just hair.

 Words from Nicole Friedland: president and CEO

“The availability of Leqselvi offers hope to our community, delivering a new, effective treatment option for adults living with severe alopecia areata,” said Nicole Friedland, president and CEO, National Alopecia Areata Foundation (NAAF). “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.”

Common adverse effects

•  Leqselvi may cause serious side effects including serious infections, malignancies, thrombosis, gastrointestinal perforations, and certain laboratory abnormalities. 
• There also may be an increased risk of mortality and major cardiovascular events. 
• Leqselvi should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors. 
• In placebo-controlled trials, the three most common adverse events were headache (12.4% as compared to 9.4% with placebo), acne (10% as compared to 4.3% with placebo), and nasopharyngitis (8.1% as compared to 6.7% with placebo). 

Sun Pharma for Leqselvi

• Sun Pharma is committed to making Leqselvi accessible to patients through the Leqselvi Support Programme, which offers eligible patients the opportunity to receive their medication for as little as $0 for up to two years. 
• The program also provides access to a dedicated Patient Access Liaison— someone who will guide patients through the process, answer questions, and offer personalized support every step of the way.

Leqselvi & alopecia areata

• Leqselvi (deuruxolitinib) 8 mg tablets is an oral selective inhibitor of Janus kinases JAK1 and JAK2 approved for the treatment of adults with severe alopecia areata. 
• 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. 
• Alopecia areata may affect up to 2.5% of the United States and global population during their lifetime. 
• The scalp is the most commonly affected area, but any hair-bearing site can be affected alone or together with the scalp. 
• Onset of the disease can occur throughout life and affects both women and men. 
• Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. There are currently limited approved treatment options available for alopecia areata.

The trials: THRIVE-AA1 and THRIVE-AA2

• THRIVE-AA1 and THRIVE-AA2 (NCT04518995 and NCT04797650) were randomized, double-blind, placebo-controlled clinical trials in 1223 adult patients ages 18-65 with severe alopecia areata at sites in the US, Canada and Europe evaluating the regrowth of scalp hair after 24 weeks of dosing using the Severity of Alopecia Tool (SALT) score. 
• Patients were randomized to receive either 8 mg twice daily or 12 mg twice daily of deuruxolitinib or placebo for 24 weeks. 
• The primary endpoint was the percentage of patients achieving a SALT score of 20 or less at 24 weeks. 
• Patients enrolled in THRIVE-AA1 and THRIVE-AA2 were required to have at least 50 per cent scalp hair loss due to alopecia areata, as measured by SALT. 
• A SALT score of 100 represents total scalp hair loss, whereas a score of 0 represents no scalp hair loss. The average baseline SALT score across all patients in THRIVE-AA1 and THRIVE- AA2 was approximately 85.9 and 87.9 respectively.

About Sun Pharma

Sun Pharma is the world’s leading specialty generics company with a presence in specialty, generics and consumer healthcare products. It is the largest pharmaceutical company in India and is a leading generic company in the US as well as global emerging markets.