Lundbeck announced today that the Psychopharmacology Drug Advisory Committee (PDAC) appointed by the US Food and Drug Administration (FDA) voted unanimously that Serdolect (sertindole) is efficacious in the treatment of patients with schizophrenia, though they did not find the data robust enough to support an additional regulatory claim related to treatment of suicidal behaviour in schizophrenia.
The majority of the committee voted against its use in a broad schizophrenia population due to safety concerns, however a majority of the committee voted that there may be subpopulations in which the therapy is beneficial with appropriate labeling and risk management tools.
Lundbeck will work closely with the agency to define the appropriate indication and risk management program to support approval of Serdolect.
The FDA is not bound by the committee’s recommendation, but usually follows its advice. The target Prescription Drug User Fee Act (PDUFA) date for the Serdolect application is May 15, 2009. If approved, Lundbeck Inc., the company’s wholly owned US subsidiary, will market the product.
“We are pleased with the Advisory Committee’s recommendation in support of the efficacy of Serdolect in the treatment of schizophrenia and the acknowledgement of its potential safe use in the right populations with appropriate risk management measures as it is important for patients to have multiple treatment options,” said Executive Vice President Anders Gersel Pedersen, Head of Drug Development at Lundbeck.
“There continues to be a significant unmet medical need for a less sedating treatment for people with schizophrenia who may experience impaired cognition with other existing therapies and for a medication to treat suicidality in schizophrenia. We will continue to work closely with the FDA as the agency moves toward an action on the new drug application for Serdolect.”
The committee reviewed comprehensive data from clinical trials. Results from short-term, double-blind, fixed-dose, placebo- and active-controlled studies demonstrated that Serdolect was superior to placebo in treating the positive and negative symptoms associated with acute exacerbation of schizophrenia.
With nearly 10,000 patients and approximately 15,000 patient years of exposure, the Sertindole Cohort Prospective (SCoP) study showed that the all-cause mortality with Serdolect was comparable to that with risperidone. During randomised treatment (only Serdolect or risperidone), the all-cause mortality rate for Serdolect was 0.63 deaths per 100 patient years, which was the same as that observed for risperidone.
The outcome of the SCoP study further confirmed that although a higher cardiovascular event rate is seen for patients treated with Serdolect, the event rate related to arrhythmia remains very low.