Leqselvi FDA Approval History
Last updated by Judith Stewart, BPharm on July 30, 2024.
FDA Approved: Yes (First approved July 25, 2024)
Brand name: Leqselvi
Generic name: deuruxolitinib phosphate
Dosage form: Tablets
Company: Sun Pharmaceutical Industries Inc.
Treatment for: Alopecia Areata
Leqselvi (deuruxolitinib) is a Janus kinase (JAK) inhibitor indicated 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.
- Leqselvi contains deuruxolitinib, a JAK1/JAK2 inhibitor that works in the treatment of alopecia areata by targeting the γc cytokine and interferon-gamma (IFN-γ) signaling pathway to reverse hair loss.
- FDA approval of Leqselvi was based on data from the Phase 3 clinical trials THRIVE-AA1 and THRIVE-AA2 which evaluated the regrowth of scalp hair after 24 weeks, and two long-term extension trials in which patients were eligible to enroll upon completion of the 24-week trials. At the study baseline, the average patient had only 13% of their scalp hair coverage. In the trials, the primary endpoint was met with more than 30% of patients taking Leqselvi experiencing 80% or more scalp hair coverage at 24 weeks. Additionally, up to 25% of patients had ≥90% scalp hair coverage at 24 weeks.
- Leqselvi tablets are administered orally, twice daily.
- The Leqselvi product label carries a Boxed Warning for serious infections, a higher rate of all-cause mortality, an increased risk of malignancies such as lymphomas and lung cancers, higher rate of major adverse cardiovascular events (MACE), and an increased incidence of thrombosis. Warnings and precautions include gastrointestinal perforations and certain laboratory abnormalities.
- Common adverse reactions include headache, acne, nasopharyngitis, increased blood creatine phosphokinase, hyperlipidemia, fatigue, increased weight, lymphopenia, thrombocytosis, anemia, skin and soft tissue infections, neutropenia, and herpes.
Development timeline for Leqselvi
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.