First medication ever approved for this Indication in Europe
Basel, 10 July 2003 - Novartis announced today that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorisation for Leponex® (clozapine). In addition to the treatment of schizophrenic patients who fail to respond adequately to standard antipsychotic drug therapies, Leponex is now also indicated for long-term reduction of the risk of recurrent suicidal behaviour in patients with schizophrenia or schizoaffective disorder who are judged to be at such risk based on their clinical history and current clinical picture. This action by Swissmedic marks the first time in Europe that any medication has been approved for use in specifically treating the risk of suicidal behaviour.
The approval is based upon data from the International Suicide Prevention Trial (InterSePT(TM)), the first ever study to prospectively evaluate a medication in reducing the risk of suicidal behaviour.1 The findings from this two-year landmark study led the US Food and Drug Administration (FDA) to approve the drug - marketed in the US under the brand name Clozaril® - in December 2002 for the treatment of recurrent suicidal behaviour in schizophrenic and schizoaffective patients who are at chronic risk.
"The risk of suicide attempts in people with schizophrenia is appallingly high and use of Leponex in this population could very well help to save many lives each year," said Dr. Herbert Meltzer, Bixler Chair of Psychiatry and Professor of Pharmacology at Vanderbilt University, and lead author of the publication which appeared in the Archives of General Psychiatry earlier this year. "The InterSePT study showed that for every 13 patients treated with clozapine, there was one less serious suicidal event."
"The findings of the InterSePT study represent an important advance for patients with schizophrenia, their relatives and their physicians," commented Thomas Ebeling, Chief Executive Officer, Division Pharma. "We are very pleased that Swissmedic has recognized the potential of treatment with Leponex to reduce the risk of suicidal behaviour for those patients who are most in need and that Switzerland is the first country in Europe to approve this important new indication for Leponex ".
About suicidal behaviour
Schizophrenia affects up to 24 million people worldwide. Suicide is the leading cause of premature death among patients with schizophrenia and schizoaffective disorder. 40% of patients with these disorders will attempt suicide at least once during their lifetime and 10% will die by suicide. Suicidal behaviour includes symptoms ranging from having persistent suicidal thoughts, to making suicidal plans and attempting suicide.
About InterSePT(TM)
InterSePT was a multi-center, randomized study initiated in 1998 to compare the efficacy of two antipsychotic compounds, Leponex and olanzapine, in reducing the risk of suicidal behaviour among patients with schizophrenia or schizoaffective disorder. Leponex reduced the risk of suicidal behaviour (suicide attempts and hospitalisations to prevent suicide) by 26% compared to olanzapine. This advantage was not related to the greater use of concomitant psychotropic medication by Leponex-treated patients who actually required fewer such medications.
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References:
Meltzer, HY, et al.Clozapine Treatment for Suicidality in Schizophrenia: International Suicide Prevention Trial (InterSePT) Arch Gen Psychiatry. 2003; 60:82-91
The press release can also be downloaded from the following link:
