Novartis launches Exelon in UK for PD dementia

Swiss drug major Novartis' Exelon (rivastigmine tartrate) has been introduced in the UK for mild-to-moderate dementia associated with Parkinson's disease. The agent, which is currently approved for the treatment of mild-to-moderate Alzheimer's disease, has been cleared to treat the 12,000 PD sufferers in the UK, making it the first medicine to become available for the dementia indication.

Novartis noted that about 40% of patients with PD are estimated to also develop dementia, which can have a devastating effect on patients and their families. Also, the risk of dementia among PD patients is approximately four to six times higher than among elderly people without it.

The drug's European approval is based on the results of the EXPRESS study, a large-scale, 24-week, randomized, well-controlled trial involving 541 patients from 12 centers in Europe and Canada. These showed a statistically-significant improvement in overall functioning in patients treated with Exelon relative to the deterioration seen in those given placebo, in cognition and certain aspects of behavior. Additionally, Exelon patients had less deterioration in their ability to perform activities of daily living, Novartis noted. This clinical data also supported the positive decision on the drug from the Europe Union's Committee for Medicinal Products for Human Use, earlier this year (Marketletter February 6).