Sun Pharmaceuticals announced the US launch of deuruxolitinib (Leqselvi), an oral JAK1/2 inhibitor approved for treating severe alopecia areata in adults. The 8 mg tablets are now available to healthcare providers and patients aged 18 years and older with severe alopecia areata, a condition affecting up to 2.5% of people in the US at some point in their lives.
Clinical Evidence and Efficacy
The FDA approved deuruxolitinib in July 2024 based on positive results from two pivotal phase 3 trials, THRIVE-AA1 (NCT04518995) and THRIVE-AA2 (NCT04797650), which included more than 1,200 adult patients across the US, Canada, and Europe. The trials demonstrated significant hair regrowth outcomes, with approximately one-third of patients achieving ≥80% scalp hair coverage by week 24, and up to 25% reaching nearly full regrowth (≥90% coverage).
Patients entered the studies with an average of only 13% hair coverage, and treatment with deuruxolitinib showed a progressive regrowth trajectory with no plateau observed at 24 weeks. Participants were randomized to receive either 8 mg or 12 mg of deuruxolitinib twice daily or placebo, with the primary endpoint being reduction of the Severity of Alopecia Tool (SALT) score to 20 or less at 24 weeks.
Long-term Durability Data
Recent long-term data presented at the 2024 Fall Clinical Dermatology Conference highlighted sustained efficacy of deuruxolitinib 8 mg twice daily. In pooled open-label extension studies of the THRIVE-AA1 and THRIVE-AA2 trials, 48.8% of patients achieved a SALT score ≤20 by week 68, with 76.6% reaching that threshold using observed data. Notably, 99.6% of initial responders maintained their response, demonstrating the durability of hair regrowth.
Safety Profile
In clinical trials, the most common side effects were headache (12.4%), acne (10%), and nasopharyngitis (8.1%), compared to lower rates among placebo recipients. As with many immune-targeting therapies, deuruxolitinib carries safety risks that require careful consideration by patients and physicians.
Patient Access and Support
Sun Pharmaceuticals has launched the Leqselvi Support Program to improve treatment access for eligible patients, offering the medication for as little as $0 for up to two years. The program includes support from a patient access liaison to provide personalized assistance throughout the treatment process and help guide patients through insurance and access procedures.
Expert Perspectives
"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."
Nicole Friedland, president and CEO of the National Alopecia Areata Foundation (NAAF), emphasized the impact for patients: "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 launch addresses a key patient need, as Sun Pharma reports that 83% of patients prefer treatment options that deliver rapid results. The physical effects of alopecia areata are often accompanied by psychological distress, including anxiety and reduced self-confidence, making the drug's speed and visible results particularly significant for this patient population.
