Deuruxolitinib (Leqselvi, Sun Pharma) is now available in the U.S. for severe alopecia areata.
An oral selective inhibitor of Janus kinases JAK1 and JAK2, it is the third JAK inhibitor approved to treat alopecia areata.
Eight-mg tablets of deuruxolitinib 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 in as quickly as 8 weeks.
The U.S. Food and Drug Administration (FDA) approved deuruxolitinib for adults with severe alopecia areata in 2024. Incyte then filed a lawsuit against Sun Pharma, stating that the drug infringed on a U.S. patent. The New Jersey federal court handed down an injunction blocking the drug’s rollout. The injunction, now lifted, had prevented Sun from launching the medication.
“The clinical evidence for LEQSELVI is truly compelling, demonstrating consistent efficacy,” says Arash Mostaghimi, MD, MPA, MPH, FAAD, Vice Chair of Clinical Trials and Innovation and Associate Professor of Dermatology at Brigham and Women’s Hospital in Boston, MA, in a news release. “LEQSELVI provides clinicians with an important new treatment that can deliver significant, rapid outcomes for patients with alopecia areata.”
“The availability of LEQSELVI offers hope to our community, delivering a new, effective treatment option for adults living with severe alopecia areata,” adds 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.”
Deuruxolitinib 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. It should not be used in patients who are CYP2C9 poor metabolizers or who are taking moderate or strong CYP2C9 inhibitors.
Sun Pharma is committed to making deuruxolitinib 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 and offer personalized support every step of the way. For more information about LEQSELVI, visit LEQSELVI.com.
