FDA Approves New Indications for J&J’s Antipsychotic Invega Sustenna

The FDA approved two sNDAs for Johnson & Johnson’s antipsychotic Invega Sustenna to treat patients with schizoaffective disorder, which will help the drugmaker offset lower sales of its neurological treatments due to generic competition.

Invega Sustenna (paliperidone palmitate) won clearance as a monotherapy or in combination with mood stabilizers or antidepressants. The product is the first once-monthly treatment for schizoaffective disorder as a monotherapy, J&J subsidiary Janssen said.

Schizoaffective disorder is a condition that causes psychotic and mood symptoms. The sNDA approvals were based on a study that showed a significant delay in relapse in the symptoms of the disorder, Janssen said.

Janssen has another sNDA currently under FDA review to revise Invega Sustenna’s labeling to include new data showing significantly delayed time to relapse when compared with other antipsychotic therapies in treating schizophrenia, spokeswoman Robyn Frenze said.

Invega Sustenna already generated $1.2 billion in sales last year as a treatment for schizophrenia in adults, according to J&J’s annual financial report. The high sales have helped J&J offset declining revenue from other neuroscience drugs such as the bipolar treatment Risperdal (risperidone) and the attention deficit disorder drug Concerta (methylphenidate) due to generic competition. — Robert King

Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.