Nov 6 (Reuters) - The U.S. Food and Drug Administration
has approved the expanded use of Johnson & Johnson's ( JNJ )
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.