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FDA Issues not approvable letter to Lilly


Eli Lilly and Company has received a not approvable letter from the US Food and Drug Administration (FDA) for Zyprexa® long-acting injection (olanzapine LAI) for the treatment and maintenance treatment of schizophrenia in adults, the company announced.

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% of patients in clinical trials.

These events were discussed during the FDA’s 6 February 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 6 February hearing. Lilly alerted the agency and the advisory committee about the existence of a possible new case on February, 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 three to five hours after injection. All previous excessive sedation events had begun within three hours of injection. As with all previous patients with excessive sedation, this patient 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 Dr Jennifer Stotka, Vice President of US Regulatory Affairs, Eli Lilly and Company.

“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.”

Independent regulatory reviews of Zyprexa LAI applications are ongoing in the European Union and other countries including Canada and Australia.

Eli Lilly and Company

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