US FDA expands use of J&J’s Caplyta as add-on depression drug

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By Sneha S K

(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.

What Caplyta “has been able to do in terms of efficacy, providing a path to remission for patients, being relatively easy to start on and stay on. We think this is foundational to really improving wellbeing for individuals who have this debilitating disorder,” said Bill Martin, global therapeutic area head, Neuroscience at J&J.

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. It brought in worldwide sales of $240 million in the third quarter.

The expanded approval for Caplyta 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, measured on a disease severity scale.

Data also showed that Caplyta did not increase mean weight gain, metabolic changes, or reported sexual side-effects.

Caplyta is an oral, once-daily atypical antipsychotic whose mechanism of action is currently unknown. It is also being studied for other neuropsychiatric and neurological disorders.

(Reporting by Sneha S K in Bengaluru; Editing by Shailesh Kuber and Alan Barona)