FDA Issues Not-Approvable Letter for Lilly's Zyprexa(R) Long-Acting Injection (LAI) for Schizophrenia...( INDIANAPOLIS Feb. 28 /- Eli Lilly...),Health

INDIANAPOLIS, Feb. 28 /PRNewswire-FirstCall/ -- Eli Lilly and Company (NYSE: LLY) has received a not approvable letter from the U.S. Food and Drug Administration for Zyprexa(R) long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced today. Zyprexa LAI is an investigational formulation that combines the atypical antipsychotic medication Zyprexa (olanzapine) with a pamoate salt, resulting in an extended delivery of up to four weeks.

In its letter, the FDA said it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about 1 percent of patients in clinical trials. These events were discussed during the FDA's Feb. 6 Psychopharmacologic Drugs Advisory Committee hearing. At the conclusion of that meeting, the committee voted that there were circumstances under which Zyprexa LAI would be acceptably safe and effective for the treatment of acutely exacerbated schizophrenia and maintenance treatment of schizophrenia in adults.

In its letter, however, the FDA cited a new excessive sedation event that occurred shortly before the Feb. 6 hearing. Lilly alerted the agency and the advisory committee about the existence of a possible new case on Feb. 6, noting that Lilly was investigating the details of the event including conflicting information about the time of onset. After collecting additional information, Lilly was able to confirm after the advisory committee hearing that this was a case of excessive sedation and that it began between 3 to 5 hours after injection. All previous excessive sedation events had begun within three hours of injection. As with all previous patients with excessi
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