- Cariprazine, which is being co-marketed by Allergan and Gedeon Richter, is a newly approved drug for the treatment of schizophrenia and bipolar disorder.
- Cariprazine was rejected by the FDA in 2013, but won approval this time around based on new phase 3 data.
- This new drug, which is branded as Vraylar, was once considered to have blockbuster potential, but considering its long path to market, those aspirations have been downgraded.
When the FDA requested more information, Allgergan and Richter went back to the clinical trial drawing board and subsequently resubmitted a dossier of data to the FDA which included data on 2,700 patients with schizophrenia or bipolar disorder. In the study, Vraylar met its endpoint of reducing schizophrenic relapses compared with placebo.
Vraylar came to Allergan via various deals, which involved Richter outlicensing it to Forest in 2004, before it was acquired by Actavis for $25 billion in 2014. (Actavis bought Allergan for $66 billion last year and took the name Allergan). At this point, analysts are looking for $200 million in annual sales.