US FDA expands use of J&J's Caplyta as add-on depression drug
The U.S. FDA has approved Johnson & Johnson's Caplyta as an add-on treatment for major depressive disorder, following its acquisition of Intra-Cellular Therapies. This marks the first approval for a drug from Intra-Cellular post-acquisition. Caplyta, already approved for schizophrenia and bipolar disorder, can now be used alongside oral antidepressants. The decision is based on late-stage studies showing significant symptom improvement in depression. Caplyta is an atypical antipsychotic taken once daily, with its mechanism of action currently unknown.
Nov 6 (Reuters) - The U.S. Food and Drug Administration has approved the expanded use of Johnson & Johnson’s (JNJ.N) 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.
