Advisors to the US Food and Drug Administration have said that Lundbeck’s antipsychotic Serdolect is acceptably safe for some patients with schizophrenia but voted firmly against recommending the drug for the broad treatment of the disorder.
The FDA’s Psychopharmacologic Drugs Advisory Committee voted 12 to 1 that Serdolect (sertindole) is not “acceptably safe” for the general population who suffer from schizophrenia. The panellists cited their concerns about the cases of sudden cardiac death in a Lundbeck study of about 10,000 patients who were given either Serdolect or Johnson & Johnson’s antipsychotic Risperdal (risperidone).
The panellists also voted 12-1 against Lundbeck’s claim that the drug could help prevent suicide among schizophrenics among the 50% of patients that attempt to do so, according to the drugmaker. An FDA analysis had noted that 36 sertindole-treated patients attempted suicide, compared with 54 in the risperidone group, but the difference failed to reach statistical significance.
Nevertheless, the panel voted 8-2, with three abstentions, that certain patients. possibly those do not respond adequately to current therapies, could benefit from taking Serdolect. Also the committee unanimously agreed that Serdolect is effective.
Panel chairman Wayne Goodman was quoted as saying that “I’m cognisant of the need for having available an array of different treatments for this devastating condition”. The FDA will consider the recommendations and is expected to make a decision by May 15.
Anders Gersel Pedersen, head of drug development at Lundbeck, said the firm is pleased with the advisory committee’s recommendation in support of the efficacy of Serdolect “and the acknowledgement of its potential safe use in the right populations with appropriate risk management measures”. He added that “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”.
Dr Pedersen went on to say “we will continue to work closely with the FDA as the agency moves toward an action on the New Drug Application for Serdolect”. The company also noted that during randomised treatment on the Sertindole Cohort Prospective study, ie only Serdolect or risperidone, the all-cause mortality rate for its drug was 0.63 deaths per 100 patient years, which was the same as that observed for the J&J therapy.
That 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”, Lundbeck added. The original application for US approval was filed in 1995 but Serdolect was withdrawn globally in 1998 after it was linked to cardiac arrhythmias and arrests.
However it returned to the European market in 2006 on the basis of new clinical data but also new safeguards were put in place, 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.
