(Reuters) -The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s drug Caplyta as an add-on treatment for adults with major depressive disorder, the company said on Thursday.
J&J gained access to Caplyta with its $14.6 billion acquisition of neurological drugmaker Intra-Cellular Therapies in January. The FDA’s decision marks the first approval for a drug from the Intra-Cellular stable after the deal.
Caplyta can now be used as an adjunctive therapy for patients with depression in combination with oral antidepressants.
Major depressive disorder, or clinical depression, is one of the most common psychiatric disorders, affecting about 22 million American adults, according to the company.
Caplyta is already approved in the U.S. to treat schizophrenia and depressive episodes associated with bipolar disorder.
The expanded approval was based on data from two late-stage studies in which the drug showed significant improvement in depression symptoms compared to an oral antidepressant plus placebo.
Caplyta is an oral, once-daily atypical antipsychotic whose mechanism of action is currently unknown.
(Reporting by Sneha S K in Bengaluru; Editing by Shailesh Kuber)
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