Novartis withdraws application for Exelon/Prometax extended indications
Drug Delivery Insight Update
The EMA has been notified by Novartis Europharm of the latter’s decision to withdraw its applications for an extension of the therapeutic indication for Exelon and Prometax (rivastigmine), 4.6mg/24h and 9.5mg/24h transdermal patches.
In March 2011, Novartis submitted an application to extend the marketing approvals for the two transdermal patches to include a new indication for the symptomatic treatment of mild to moderately severe dementia in patients with idiopathic Parkinson’s disease. At the time of the withdrawal, the application was under review by the EMA’s Committee for Medicinal Products for Human Use (CHMP). Exelon was first approved in the EU in May 1998, and its duplicate, Prometax, was approved in December 1998. The transdermal patches are currently intended for the symptomatic treatment of mild-to-moderately severe Alzheimer’s disease.
The company stated that it decided to withdraw the application after the CHMP indicated that in order to conclude a favourable approval additional data was required, which could not be generated within the time-frame allowed in the centralised procedure. Both medicines continue to be approved in the currently approved indications.
Article source: Espicom’s business publication Drug Delivery Insight, edited by Sophie Bracken.
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