Zyprexa LAI gets FDA non-approvable letter

US drug major Eli Lilly has received a "non-approvable" letter from the Food and Drug Administration for Zyprexa long-acting injection (olanzapine LAI) as a treatment and maintenance therapy for schizophrenia in adults. The decision follows reports of excessive sedation events associated with the drug (Marketletter February 18).

The FDA said that, although its Psychopharmacologic Drugs Advisory Committee recently voted in favor of approving Zyprexa LAI, it had decided not to follow the guidance due to ongoing concerns about several cases of "excessive sedation" that began between three and five hours after administration. The agency explained that all previous sedation events of this kind had begun within three hours of injection and, on that basis, occurrences outside this time-frame needed full examination.

"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, vice president of US regulatory affairs at the Indianapolis-headquartered firm. "Given the chronic and severe nature of schizophrenia, persistent challenges with adherence, and the limited number of approved depot formulations, we continue to believe that, if approved, Zyprexa LAI would provide a valuable treatment option for patients suffering from schizophrenia," she added.