Danish drugmaker H Lundbeck has launched its schizophrenia drug Serdolect (sertindole) in Estonia, its first European market.
Although first introduced in 1996, sertindole was voluntarily withdrawn from markets around the world two years later after it was linked to cardiac arrhythmias and cardiac arrests. Lundbeck continued to carry out clinical trials of the drug, and says it now has data on more than 17,000 patients who have received the drug which support its safety.
In 2002, a European Medicines Agency’s advisory committee recommended that sertindole could return to the market, on the basis of new clinical data but also new safeguards including a dose reduction from 24mg to 20mg once-daily, more stringent warnings on labelling and extensive requirements for patients to undergo ECG monitoring before and during treatment.
A spokesman for Lundbeck said that these safeguards have been taken into account, and Serdolect was approved last April by the European Medicines Agency with a dose range of 16mg-20mg, carries a warning on the label that it can cause QT elevations (a marker for cardiovascular risk) and patients receiving the drug will be monitored using ECG testing.
The significance of these restrictions on Serdolect’s marketing potential remains to be seen, but a link to QT elevations has not proved a major problem for another schizophrenia drug, Pfizer’s Geodon (ziprasidone). This agent was launched in 2001 in the USA and, while it has not achieved the blockbuster status of the leading antipsychotic brands, such as Eli Lilly’s Zyprexa (olanzapine) and Johnson & Johnson’s Risperdal (risperidone), has seen its sales growth accelerate of late, rising 22% to $148 million in the third quarter of 2005.
Lundbeck also noted that it remains in discussions with the US Food and Drug Administration (FDA) about seeking approval for Serdolect there, and expects to provide an update on that within the next six months. The product was formerly licensed to Abbott Laboratories in the USA, but Lundbeck regained worldwide rights after Abbott withdrew its marketing application for the drug in 1998.