The Wall Street Journal-20080205-Lilly Gets Support for Version Of Schizophrenia Treatment
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Lilly Gets Support for Version Of Schizophrenia Treatment
Full Text (361 words)WASHINGTON -- A Food and Drug Administration official said that a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zyprexa was effective at treating schizophrenia, but caused "profound sedation" in certain patients.
A memo written by Thomas P. Laughren, the FDA's psychiatry products division director, and posted on the agency's Web site, said clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection. The FDA said the sedation typically lasted about one to three hours.
The long-acting form of Zyprexa faces a review by an FDA panel of outside medical experts tomorrow. The panel will be asked if that form of Zyprexa has been shown to be "acceptably safe" and effective for the treatment of schizophrenia. The panel's decision will amount to a recommendation about whether the FDA should approve the product. The FDA usually follows its panel's advice but isn't required to.
Zyprexa is approved as an oral, once-daily medication to treat schizophrenia and bipolar disorder. The drug had $4.8 billion in sales last year. There is a short-acting injectable form that is used to treat agitated, noncooperative patients with schizophrenia or bipolar mania.
Lilly is seeking FDA approval of the long-acting form of Zyprexa for the treatment of schizophrenia, which could be injected every two or four weeks. The product would be administered in a doctor's office.
The FDA said the panel also will be asked to make recommendations about whether long-acting Zyprexa should carry a "black box" warning -- the FDA's toughest drug precaution, which appears at the top of a product's label -- or if the agency should consider approving the product for so-called second line use after other drugs fail.
Lilly said the profound sedation associated with the long-acting, injectable form of Zyprexa can be safely managed and said patients and health-care providers can be adequately warned of the risk. The FDA said the sedation seen with the long-acting form of Zyprexa appears unique to the injectable form of the drug and likely results from the rapid release of the drug into a patient's body after being injected.
