Zeneca Files First European Seroquel Dossier

Zeneca has submitted a Marketing Approval Application in the UK for Seroquel (quetiapine), the first European submission for the atypical antipsychotic. The drug has already been submitted for approval in the USA, and other submissions are expected over the next few months, according to the firm.

Seroquel is one of several new antipsychotics coming through to market which offer equivalent efficacy to existing dopamine antagonists such as haloperidol, but which are characterized by a lower propensity to cause adverse reactions, particularly extrapyramidal side effects.

The EPS-sparing properties of these new drugs, which include Eli Lilly's Zyprex (olanzapine), Pfizer's ziprasidone and Lundbeck/Abbott's Serdolect (sertindole), may be connected to their receptor profiles. Like the archetypal atypical antipsychotic, Sandoz' clozapine, they all have relatively low affinity for the dopamine D2 receptor (Marketletters passim). Unfortunately, despite its efficacy clozapine use is limited to second-line as it is associated with a 1% incidence of potentially life-threatening agranulocytosis.