Orion withdraws MAA for expanded Stalevo label

The European Medicines Agency (EMEA) has been formally notified by Orion Corp of its decision to withdraw its application for an extension  of indication for the centrally-authorized drug Stalevo (levodopa,  carbidopa, entacapone) film-coated tablets. In April 2008, Orion sought  to expand the label to include its use in the initiation of levodopa in  early Parkinson's disease. The drug recently missed the primary  endpoint in a trial of 747 patients with early PD requiring levodopa  treatment (Marketletter March 2). The agent did not delay the onset of  dyskinesia associated with wearing off of levodopa, failing to support  the extension.