Mylan Laboratories Inc announced that its branded-drug subsidiary, Bertek Pharmaceuticals Inc., received notice from the US Food and Drug Administration (FDA) following their priority review that Apokyn (apomorphine hydrochloride injection) has been approved as the first and only therapy in the United States for the acute, intermittent treatment of hypomobility, "off" episodes ("end-of-dose wearing off" and unpredictable "on/off" episodes) associated with advanced Parkinson's disease.
"This is a significant day for the Parkinson's community and another milestone in Mylan's mission to develop pharmaceutical products that address unmet medical needs," said Robert J. Coury, Mylan vice chairman and CEO.
The FDA approval clears the way for Bertek to market Apokyn and provides a new therapy for "off" episodes, one of the most debilitating aspects suffered by patients with Parkinson's disease. The approval includes post marketing study commitments, but will not impact market introduction of this important product. The product will be available by July 2004 and distributed through a limited specialty pharmacy network. Apokyn has orphan drug status, a federal designation to indicate the drug's exclusive use in treating a condition affecting fewer than 200,000 people in the United States. Apokyn will be the third orphan drug marketed by Mylan and Bertek.
Apokyn provides patients with an effective treatment to use during an 'off' episode. "Off" episodes are debilitating periods of partial loss of movement or total immobility experienced by patients with advanced Parkinson's disease. As Parkinson's disease progresses, patients begin to experience immobilizing "off" episodes despite treatment with drugs used to increase or replace dopamine.
Apokyn is not used to prevent "off" episodes and it does not replace other Parkinson's disease medications, but rather treats an existing "off" episode when it occurs. As an acute, rescue treatment, Apokyn helps patients experiencing a debilitating "off" episode to walk, talk or move around easier. The intensity, duration and frequency of "off" episodes vary for each sufferer. Patients with Parkinson's disease lose motor control during "off" episodes, making routine tasks such as walking and even speaking extremely difficult. Patients with Parkinson's or their caregivers administer the medication via injection under the skin.