European regulators have approved Gedeon Richter’s novel antipsychotic Reagila as a new option for the treatment of patients with schizophrenia.
In clinical trials the drug, a potent dopamine D3/D2 receptor partial agonist atypical antipsychotic, significantly improved symptoms of the condition and also reduced the risk of relapse by 55 percent versus placebo.
In August last year, Richter and Recordati signed an exclusive license agreement to commercialise Reagila (cariprazine) in Western Europe, in Algeria, in Tunisia and in Turkey.
"We are very pleased with the European Commission's decision to authorise the marketing of cariprazine, a novel antipsychotic which represents an additional treatment option for patients suffering from schizophrenia, a complex condition for which a medical need for new treatment options persists", noted Andrea Recordati, the firm’s vice chairman and chief executive.
“I am confident that Reagila will quickly be accepted as an important new medication for the management of schizophrenia by the specialized medical community in all territories.”
The drug is licensed to Allergan in Canada and the US, where it was approved by the US Food and Drug Administration in 2015 under the brand name Vraylar for the treatment of both schizophrenia and bipolar mania.