Johnson & Johnson (JNJ) announced on Thursday that the U.S. Food and Drug Administration has further expanded the labeling for its atypical antipsychotic Caplyta to approve its use in adults with major depressive disorder.
The oral drug, which J&J (JNJ) added to its pipeline through its $14.6B acquisition of Intra-Cellular Therapies this year, had previously been approved by the FDA for adults with schizophrenia and bipolar depression.
The latest approval was based on data from two global Phase 3 trials, which met their primary and key secondary endpoints, indicating an improvement in depression symptoms with a statistically significant and clinically meaningful effect, the company said.
“CAPLYTA has the potential to become a new standard of care across multiple mental health disorders, including major depressive disorder,” said Bill Martin, J&J’s global therapeutic area head for neuroscience.
In July, JNJ submitted a supplemental New Drug Application for Caplyta, seeking another label expansion for the once-daily therapy in the prevention of relapses seen in patients with schizophrenia.