16. March 2012 14:10
Novartis Europharm has withdrawn its application to extend the therapeutic indications of Exelon and Prometax from the EMA.
The company had hoped to extend the use of the transdermal patches for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease.
However, in its official letter to the EMA, Novartis said it was unable to provide the data required within the timeframe allowed.
Exelon was first authorised for use in the EU on 12 May 1998. Its duplicate Prometax was first authorised in December that year.
They are both currently indicated for the symptomatic treatment of mild to moderately severe Alzheimer’s dementia.
The EMA says that both medicines continue to be authorised in the currently approved indication, and that the withdrawal does not prejudice the possibility of a company making a new application at a later stage.