Schering-Plough has filed its investigational schizophrenia drug asenapine, which analysts believe could be a blockbuster, in Europe.
The European Medicines Agency has accepted for review the company’s Marketing Authorisation Application for asenapine, which if approved will be sold as Sycrest, for the treatment of schizophrenia and manic episodes associated with bipolar I disorder. The MAA for Sycrest, a sublingual tablet, includes data from a clinical trial programme involving more than 3,000 patients.
Commenting on the filing, Thomas Koestler, president of the Schering-Plough Research Institute, said that “we highlighted asenapine as one of the ‘five stars’ in our late-stage R&D pipeline” at a meeting in November 2008. At that time, S-P had said that a filing in Europe would happen some time in the next year so “I am pleased that we met this important milestone for asenapine within the first half of 2009”.
At the beginning of this year, S-P received a complete response letter from the US Food and Drug Administration about asenapine, which will be sold as Saphris there. The letter included proposed labelling for both indications and a request for supplemental data from the existing asenapine database but the company stressed that no additional clinical trials have been requested.
S-P acquired asenapine in November 2007 through its acquisition of Organon BioSciences from Akzo Nobel.
