Pfizer's antipsychotic ziprasidone gets approval in USA

7 February 2001

The US Food and Drug Administration has approved Pfizer's antipsychoticdrug ziprasidone hydrochloride for the treatment of schizophrenia. Importantly, the labeling for the product does not include a black box warning or a requirement that patients who receive it need electrocardiographic monitoring.

The FDA agency turned down Pfizer's original New Drug Application for ziprasidone in 1998 because of concerns regarding its tendency to cause cardiac disturbances (QT prolongation). Last year, an FDA panel convened to review a revamped NDA for the drug concluded that changes in the patients' electrical heart rhythms were not linked directly to reports of potentially fatal arrhythmias (Marketletter July 20, 2000).

A Pfizer spokesman told Reuters that the company had provided additional data which showed that ziprasidone was associated with less QT prolongation than two other marketed antipsychotics, although it does have a greater tendency to cause this than Eli Lilly's Zyprexa (olanzapine) and Janssen's Risperdal (risperidone), which are the two top-selling antipsychotics with annual sales of around $2.4 billion and $1.6 billion, respectively. The lack of a black box warning and no need for ECG monitoring places ziprasidone in a position to challenge the market leaders, backed by Pfizer's undoubted marketing prowess, and fulfil widely-held expectations that the drug will achieve sales in excess of $1 billion a year. Added to this, ziprasidone has certain advantageous characteristics, particularly no effect on weight. Weight gain can affect compliance with other antipsychotics.

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