FDA Panel Backs Sertindole, But Safety Issues Raised

Shortly after the first launch of the drug in the UK by originator Lundbeck, the antipsychotic sertindole has been recommended for approval in the USA by the Food and Drug Administration's Psychopharmacologic Drugs Advisory Committee. Sertindole is licensed to Abbott Laboratories in the USA, which will market it as Serlect.

After eight hours of debate, the panel eventually voted four to two in favor of approval for the drug to treat the psychotic symptoms of schizophrenia. Abbott will be marketing the drug on safety and tolerability issues, pointing to low rates of extrapyramidal symptoms which plague older drugs such as haloperidol. Only Janssen-Cilag's competitor drug Risperdal (risperidone) offers similar low rates, although it has been suggested that with risperdal EPS may surface when the dose rises over 3mg/day. A significant proportion of patients require doses of 4mg-8mg/day for optimum control.

Nevertheless, FDA doctors raised objections to approving sertindole, largely based on the fact that 27 people died during the course of the studies, including 13 sudden deaths. There was no proof that the drug actually caused these deaths, but FDA cardiologist Raymond Lipicky told the panel that attention had already been focused on the drug because it is associated with QT interval prolongation, an alteration in the heart's usual rhythm which, it has been suggested, can be a precursor for more serious dysrhythmias.