Leqselvi Approved for Treating Severe Alopecia Areata
On July 25, 2024, the U.S. Food and Drug Administration (FDA) approved Leqselvi™ (deuruxolitinib – Sun Pharmaceutical). It’s a Janu kinase (JAK) inhibitor for the treatment of adult patients with severe alopecia areata. The recommended dose is 8mg twice each day. A boxed warning required by the FDA for all JAK inhibitors that are used to treat inflammatory conditions cautions that patients taking them may have a greater chance of dying, developing certain cancers, suffering cardiovascular (CV) events, having blood clots, and acquiring severe infections. Plans for its launch, distribution, and pricing are not yet available. Full prescribing information can be found here.
At a Glance
- Brand Drug: Leqselvi™ (deuruxolitinib)
- Manufacturer: Sun Pharmaceutical
- Date Approved: July 25, 2024
- Indication: treatment of adults with severe alopecia areata.
- Dosage Forms Available: 8mg oral tablets
- Launch Date: not yet available
- Estimated Annual Cost: TBD
- Alopecia areata is an autoimmune disease causing sudden hair loss on the scalp, face, and other areas of the body. Approximately 700,000 people in the United States have alopecia areata, with 300,000 having the severe form of the disease.
- Girls and women are significantly more likely to have alopecia than boys and men; individuals of African, Asian, or Hispanic descent are more likely than Caucasians.
- Frequently, alopecia areata occurs along with another autoimmune condition, such as type 1 diabetes, or with an atopic condition, such as asthma.
- Approval of Leqselvi for this use is based on data from two Phase 3 trials (THRIVE-AA1 and THRIVE-AA2) involving 1,220 patients with at least 50% scalp hair loss. At baseline, the average patient had only 13% scalp hair coverage. By week 24, almost one-third of patients experienced 80% scalp hair coverage.
- Two other JAK inhibitors, Litfulo™ (ritlecitinib – Pfizer) and Olumiant® (baricitinib – Eli Lilly and Company), are also approved for treating adults with severe alopecia areata. Litfulo is also approved for use in adolescents 12 years of age and older.
- Previous treatments involve topical products, such as minoxidil and corticosteroids, or injections of corticosteroids into the affected areas.
- Leqselvi carries the same boxed warning required by the FDA for all JAK inhibitors that are used to treat inflammatory conditions. Patients taking them may have a greater chance of death, certain cancers, adverse CV events, blood clots, and severe infections.
- Patients also should be screened for tuberculosis (TB) before starting treatment with any JAK inhibitor and periodically during therapy.
- Leqselvi should not be taken at the same time as biologic disease-modifying anti-rheumatic drugs (DMARDs), immunosuppressants or other JAK inhibitors are being used.