Janssen Seeks Approval For Six-Month Long-Acting Injectable For Schizophrenia

Janssen Pharmaceutical Companies of Johnson & Johnson is seeking approval for a six-month long-acting injectable (LAI) version of the antipsychotic paliperidone palmitate six-month (PP6M) as a treatment for schizophrenia. Janssen submitted a supplemental new drug application to the U.S. Food and Drug Administration (FDA), and intends submit a Marketing Authorization Application extension to the European Medicines Agency (EMA) for PP6M in the coming months. If approved, PP6M will be the first and only LAI schizophrenia treatment with a twice-yearly dosing regimen.

The FDA submission is based on the Route 6 Study, a randomized, double-blind . . .