FDA Doesn't Approve A Form of Lilly's Zyprexa

-Wall Street Journal Online

02/29/2008 -The Food and Drug Administration declined to approve a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zyprexa, the company said.

The Indianapolis-based company said the agency issued a "not approvable" letter for the long-acting form of Zyprexa, saying the FDA needed additional information on excessive sedation that occurred in certain patients. Lilly is seeking FDA approval of the long-acting form of the drug for use in certain patients with schizophrenia. The drug could be injected every two or four weeks.

Earlier this month, an FDA panel of outside medical advisers gave limited backing for the product and suggested the agency could approve it with restrictions. The panel said the drug was effective at treating schizophrenia, but it shared concerns raised by the FDA that the product was associated with "profound sedation" in about 1% of patients in clinical studies. In some cases, the sedation caused a loss of consciousness, and comas in others.

An FDA staff review said clinical studies of the drug showed 24 out of 2,045 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection as of Sept. 30, 2007. The FDA said the sedation typically lasted about one to three hours.

However, earlier this month Lilly received another report of profound sedation. Lilly said it was able to confirm after the Feb. 6 panel meeting that the new report was an additional case of excessive sedation and it occurred between three to five hours after injection. Previously, it was believed that the sedation events occurred within three hours of injection. The company said all patients with excessive sedation fully recovered.

"We are disappointed by the FDA's decision and we are committed to ongoing discussions to better understand the agency's perspective regarding this recent case of excessive sedation and to define the path forward and the associated timeline," said Jennifer Stotka, Lilly's vice president of U.S. regulatory affairs.

Zyprexa is currently approved as an oral, once-daily medication to treat schizophrenia and bipolar disorder.

If you or a loved one have experienced Zyprexa side effects you may be entitled to compensation. Contact the Zyprexa attorneys of Ennis & Ennis today for a free confidential case evaluation. Our on staff nurse and lawyers are standing by to answer any questions you may have regarding Zyprexa side effects, a possible Zyprexa class action lawsuit, or any other type of Zyprexa litigation.