Exelon gets EC OK for Alzheimer's disease

Swiss drug major Novartis says that its Alzhiemer's disease product Exelon (rivastigmine transdermal patch) has been approved by the European Commission. The drug has been cleared for the treatment of patients suffering from mild-to-moderate forms of the disease.

European marketing approval, which follows a similar decision by the US Food and Drug Administration earlier this year (Marketletter July 16), is based on results from the international IDEAL study. The program, which involved nearly 1,200 AD patients, demonstrated that the product had a similar level of therapeutic efficacy to the highest dose Exelon capsule formulation, in terms of the blood stream concentrations of rivastigime achieved over a 24-hour period.

Additionally, IDEAL showed that Exelon improved memory function and the ability to perform everyday activities in comparison with placebo. The transdermal patch version of the drug was also associated with fewer reports of gastrointestinal side effects than oral forms of the drug.