The FDA has approved J&J’s Caplyta (lumateperone) for major depressive disorder (MDD), based on a six-month open-label extension safety study that showed a consistent safety profile with pivotal studies and a phase 3 trial that demonstrated superior efficacy.
When taking Caplyta in combination with an oral antidepressant, 80% of MDD patients responded to treatment and 65% reached remission from depression at six months. In addition, there was no increase in mean weight gain and patients reported no metabolic changes nor sexual side effects.
Caplyta was approved for schizophrenia in 2019 and as an adjunctive and monotherapy for bipolar I and II depression in 2021. The nod for MDD is the first approval for the drug since J&J acquired it from Intra-Cellular Therapies earlier this year.