What medicine is Leqselvi (Deuruxolitinib)?

Leqselvi (Deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated for the treatment of severe alopecia areata in adults. Alopecia areata is an autoimmune disease in which the immune system attacks hair follicles, causing partial or total hair loss on the scalp and body. Leqselvi contains deuruxolitinib, a JAK1/JAK2 inhibitor that reverses hair loss by targeting the γc cytokine and interferon-γ (IFN-γ) signaling pathways to treat alopecia areata.

The FDA's approval of Leqselvi was based on data from the Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2, which evaluated scalp hair regrowth after 24 weeks, and two long-term extension trials in which patients were eligible after completing 24 weeks of the trial. At study baseline, the average patient had only 13% scalp hair coverage. In the trial, the primary endpoint was that more than 30% of patients taking Leqselvi achieved scalp hair coverage of 80% or greater at 24 weeks. Additionally, up to 25% of patients had ≥90% scalp hair coverage at 24 weeks.

Leqselvi tablets are taken by mouth twice daily. Common adverse reactions include headache, acne, nasopharyngitis, elevated blood creatine phosphokinase, hyperlipidemia, fatigue, weight gain, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes. The Leqselvi product label has a warning box warning of serious infections, higher all-cause mortality, higher risk of malignancies (such as lymphoma and lung cancer), higher rates of major adverse cardiovascular events (MACE), and higher rates of thrombosis. Warnings and precautions include gastrointestinal perforation and certain laboratory abnormalities.