PRINCETON, N.J. — Sun Pharmaceutical Industries has introduced Leqselvi (deuruxolitinib) 8 mg tablets for adults living with severe alopecia areata in the U.S.
“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 of Sun Pharma North America. “As a company committed to launching new therapeutic options which address the unmet needs of patients, adding Leqselvito 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.
“The clinical evidence for Leqselvi is truly compelling, demonstrating consistent efficacy,” said Dr. Arash Mostaghimi, , 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.
“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.
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.
