FDA panel backs limited use of Serdolect

A panel of outside experts convened by the US Food and Drug Administration voted eight to two in support of approving Danish  drugmaker H Lundbeck's Serdolect (sertindole) for certain  schizophrenia patients.

However, the committee voted 12 to one against its use in a broad  schizophrenia population due to a risk of sudden cardiac death related  to prolongation of the QTc interval.  It also did not find sufficient  evidence to support claims that it works specifically against  suicidality associated with the condition.

The FDA usually follows the advice of its expert panels and a final  decision is expected by May 12. If approved, the agent will be marketed  by Lundbeck's US subsidiary. The firm said it will work closely with the  agency to define the indication and risk management program for  Serdolect.