The US Food and Drug Administration has given the green light to Johnson & Johnson’s long-acting antipsychotic Invega Sustenna for schizoaffective disorder.
Specifically, the agency has approved J&J unit Janssen’s supplemental New Drug Applications for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The thumbs-up follows a priority review for the drug, which is already marketed for the acute and maintenance treatment of schizophrenia, making it the only FDA-approved once-monthly medication to treat schizoaffective disorder as monotherapy.
The approval is based on data from a 15-month period of a long-term maintenance study measuring ability to delay relapse in schizoaffective disorder. Invega Sustenna resulted in a statistically significant delay in relapse due to mood and psychotic symptoms compared to placebo.
Dong-Jing Fu, director of clinical development at Janssen Scientific Affairs, noted that schizoaffective disorder is a difficult-to-treat disease. However, approval of Invega Sustenna “to manage the mood as well as the psychosis that define the condition has the potential to change the lives of the 750,000 adult Americans who suffer from it”.
In 2009, J&J’s Invega (paliperidone) extended-release tablets became the first atypical antipsychotic approved to treat schizoaffective disorder.
