Seroquel shows promise in Alzheimer’s
pharmafile | March 9, 2005 | News story | Sales and Marketing |
New data shows AstraZeneca's blockbuster drug Seroquel to be effective in reducing agitation in elderly patients with Alzheimer's disease (AD).
Seroquel is currently licensed for schizophrenia and bipolar disorder and AstraZeneca is now pursuing a clinical trials programme to enter the new market and maintain the drug's rapid sales growth.
The study results are a timely boost for the company after NICE recently shocked Alzheimer's carers and stakeholders, concluding that currently recommended treatments were not sufficiently cost-effective, and should not be used on the NHS.
Pfizer/Eisai's Aricept, Shire's Reminyl, Novartis' Exelon and Lundbeck's Ebixa all stand to lose out if NICE does not give in to the barrage of complaints its preliminary recommendation has aroused.
If NICE doesn't change its view before final guidance is published this summer AstraZeneca could be well-positioned to meet demand for an effective treatment for the disease although it must first gain a licence for the indication.
The new study showed 200mg doses of Seroquel were effective in reducing agitation in elderly patients with AD without leading to a decline in cognitive function. The drug was also well tolerated, with no incidence of cerebrovascular adverse events, a problem associated with the treatment of other atypical antipsychotics for this patient group.
A 30-day follow-up trial, involving 100mg doses of Seroquel, resulted in just one cerebrovascular event. The 10-week, placebo-controlled trial involved a sub-group of 260 Alzheimer's patients randomised to Seroquel and was part of the STAR clinical trial, which examines elderly patients with dementia.
Senior director of clinical research Jamie Mullen said: "This is the biggest study undertaken for Seroquel for this indication and shows if dosed right the drug is effective at reducing agitation with Alzheimer's disease."
Global brand director of Seroquel, Nick Dunscombe, added that AstraZeneca would continue testing the drug for various indications but said it was not at the stage of submitting a package to the regulators for the treatment of Alzheimer's.
Seroquel has been licensed for the treatment of schizophrenia since 1997 and earned over $2 billion last year. It has also been licensed for the treatment of mania associated with bipolar disorder.
There are an estimated 18 million people living with dementia worldwide and up to 90% of them will experience behavioural disturbances, including symptoms of agitation.
