FDA Grants Priority to J&J Schizophrenia Drug

The U.S. Food and Drug Administration has granted priority review to Johnson & Johnson's new drug application for its schizophrenia treatment, which the company says is the longest dosing interval available for patients with the condition.

Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, has developed the atypical antipsychotic Invega Trinza. The companies said that patients must first be treated with Invega Sustenna, a once-monthly injection, for at least four months before undergoing treatment with Invega Trinza.

Invega Trinza is a three-month injection administered four times a year. "With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control," said Dr. Joseph Kwentus in the company's news release.

According to the companies, 93% of patients in a long-term maintenance trial treated with Invega Trinza didn't experience a significant return of schizophrenia symptoms. The results of the study were published in March.

The FDA grants priority review to drugs that, if approved, would offer significant improvement in the treatment of serious conditions. The designation potentially cuts the FDA decision time to six months from the standard 10 months.

The treatable mental disorder affects more than 21 million people world-wide, and one in two people living with the condition does not receive care, according to the World Health Organization.

Write to Lisa Beilfuss at [e-mail]

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