Lilly receives FDA not-approvable letter for Zyprexa

In its letter, the FDA has said that it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about one percent of patients in clinical trials. The FDA advisory committee has 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.

Jennifer Stotka, vice president of US regulatory affairs at Eli Lilly, said: “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.”