FDA approves sNDA for Janssen's Invega Sustenna in schizoaffective disorder

The US Food and Drug Administration has approved the supplemental New Drug Applications (sNDAs) from US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen for Invega Sustenna (paliperidone palmitate) for monotherapy or adjunctive therapy in schizoaffective disorder. These were approved under priority review.

It is the first and currently the only once-monthly monotherapy approved by the FDA for schizoaffective disorder, the company stated.

Dong-Jing Fu, director of clinical development at Janssen Scientific Affairs, said: “Schizoaffective disorder is a difficult-to-treat disease. 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. Janssen is proud to expand treatment options for those living with schizoaffective disorder and to provide new possibilities for the family members and friends who care for them."