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FROM THE ARCHIVES: December 19, 2002
FDA Approves Clozaril To Reduce Suicide RiskBy OTESA
MIDDLETON WASHINGTON -- Novartis AG's Clozaril Thursday became the first and only drug approved to cut the risk of suicidal behavior in people with schizophrenia, a debilitating mental disease that often leads to suicidal thoughts and attempts. The Food and Drug Administration made the announcement just six weeks after its panel of psychiatric experts recommended the drug for the novel approval after Novartis successfully compared the drug to Eli Lilly & Co.'s Zyprexa. FDA said Clozaril should be used in patients who have had suicide attempts or who are repeatedly hospitalized for suicidal behavior. Although Clozaril is viewed by the psychiatric community as a highly effective drug, its sales lag behind its competitors because patients taking Clozaril have to undergo weekly or biweekly blood tests to look out for a potentially life-threatening blood-related side effect. The side effect concerns led FDA to limit Clozaril's initial approval to only the most difficult-to-treat schizophrenics. For this year, Clozaril is expected to bring in $315 million in sales, according to Neil Sweig, pharmaceutical analyst at research firm Fulcrum Global Partners. Mr. Sweig said the additional suicide approval won't provide an uptick in sales for Clozaril in the last days of 2002, but next year it may spark a slight increase in interest in the product. "It should add some sales to the drug," Mr. Sweig said. "It would not be sufficient to make Clozaril into a much more successful drug. Sales are quite low and have been swept aside by Zyprexa and Risperdal." Clozaril, which has been on the U.S. market since 1989 ushered in a new wave of so-called atypical antipsychotic drugs. These newer products didn't produce trembling side effects the older medicines did. However, the blood toxicity associated with Clozaril led its successors to take much of the market share away from the pioneer drug. Lilly's Zyprexa is expected to far surpass Clozaril with $3.8 billion in sales, followed by $2.1 billion for Johnson & Johnson's Risperdal and $1.1 billion for AstraZeneca PLC's Seroquel, Mr. Sweig said. Generic versions of Clozaril, which have also cut into the sales of the brand-name original product, will not be able to claim treatment of suicidal behavior for 36 months according to Novartis's release. About 1% of the population or 2 million Americans have schizophrenia, a brain disorder that causes hallucinations, voices, delusions and incoherent speech. Over their lifetime, 20% to 40% of people with this disease will attempt suicide and 10% will take their own lives. FDA announced last week Clozaril is one of a number of drugs that will not be allowed into the U.S. from other countries because the blood safety information may not be included in imported products. FDA also warned consumers not to buy Clozaril on the Web. Write to Otesa Middleton at otesa.middleton@dowjones.com4
Updated December 19, 2002 5:13 p.m.
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