LEQSELVI is a Janus kinase (JAK) inhibitor that is indicated for the treatment of adults with severe alopecia areata (AA).
LEQSELVI is an oral tablet that is taken twice daily.
The FDA approved LEQSELVI based on evidence from two clinical trials of 1,209 patients with AA, who had at least 50% scalp hair loss as measured by the Severity of Alopecia Tool (SALT) for more than six months. The trials were conducted at 135 sites in five countries including the United States, Canada, France, Spain, and Poland.
LEQSELVI was evaluated in two clinical trials of 1,209 patients with severe alopecia areata.
Figure 1 summarizes how many male and female patients were enrolled in the combined clinical trials used to evaluate the efficacy of LEQSELVI.
Figure 1. Baseline Demographics by Sex, Efficacy Population
Figure 2 summarizes how many patients by race were enrolled in the combined clinical trials used to evaluate the efficacy of LEQSELVI.
Figure 2. Baseline Demographics by Race, Efficacy Population
Figure 3 summarizes how many patients by age were enrolled in the combined clinical trials used to evaluate the efficacy of LEQSELVI.
Figure 3. Baseline Demographics by Age, Efficacy Population
Figure 4 summarizes how many patients by ethnicity were enrolled in the combined clinical trials used to evaluate the efficacy of LEQSELVI.
Figure 4. Baseline Demographics by Ethnicity, Efficacy Population
LEQSELVI was shown to improve hair growth in subjects with severe AA, with around 30% of subjects experiencing 80% or more scalp hair after 24 weeks of treatment, and around 23% of subjects experiencing 90% or more scalp hair after 24 weeks of treatment.
LEQSELVI may cause serious side effects, including:
CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.
COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested.
EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial.
PLACEBO: An inactive substance or "sugar pill" that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo.
SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups.