Schering-Plough Corporation announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for Sycrest (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The application will follow the Centralized Procedure.
The MAA for Sycrest includes data from the asenapine clinical trial programme involving more than 3,000 patients in schizophrenia and bipolar mania trials.
"We highlighted asenapine as one of the Five Stars in our late-stage research and development pipeline at our R&D Update meeting in November 2008. At that time, we said that our aspirational filing date for asenapine in Europe was in 2009," noted Thomas P Koestler, executive vice president and president, Schering-Plough Research Institute. "I am pleased that we met this important milestone for asenapine within the first half of 2009."
In the United States, a New Drug Application (NDA) for asenapine, under the brand name Saphris, is currently under review by the US Food and Drug Administration (FDA) for the acute treatment of schizophrenia in adults and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy.
Schering-Plough acquired asenapine in November 2007 through its acquisition of Organon BioSciences, which developed the product.