FDA extends period of review for cariprazine for treatment of schizophrenia and bipolar- Gedeon Richter + Allergan

Gedeon Richter Plc and Allergan Plc announced that the FDA notified the companies that it will require a three-month extension to complete its review of data supporting the resubmission of the New Drug Application (NDA) for cariprazine. Cariprazine is being reviewed for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.

Comment: Actavis has changed its name to Allergan a company that it acquired recently.

Comment: Cariprazine will come to the market just as major competitors are turning generic, such as Risperdal, Seroquel and Zyprexa and so far the new drug has not got a mania/depression indication which is one of the biggest markets.The FDA has expressed concerns about side effects. All the major therapies have side effects too in this indication but thay are well known..The newer anti schizophrenia drugs are Latuda (lurasidone) from Sunovion which is already on the market and so is Fanapt (iloperidone) from Saphris/Novartis with the latter selling slowly.