Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715 (together with its subsidiaries and/or affiliated companies, "Sun Pharma") today announced LEQSELVI™ (deuruxolitinib) 8 mg tablets is now available to healthcare providers and people living with severe alopecia areata in the U.S. LEQSELVI is indicated for the treatment of adults with severe alopecia areata.
"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," 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."
With limited treatment options available to people living with severe alopecia areata in the U.S., 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.1
"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."
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.2 A medication that works fast is critical for alopecia areata patients.5 In a recent survey, 83% of patients preferred a treatment with attributes that included speed. Fast regrowth brings back more than just hair.3,5
"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."
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). Please see full Prescribing Information Including BOXED WARNING and Medication Guide and see below for Important Safety Information.1
Sun Pharma is committed to making LEQSELVI accessible to patients through the LEQSELVI SUPPORT™ Program, 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. For more information about LEQSELVI, please visit LEQSELVI.com.
About LEQSELVI™ and 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.2,4 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.
About THRIVE-AA1 and THRIVE-AA2 trial design
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 U.S., 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 percent 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.
For more information, please visit www.sunpharma.com
