The U.S. Food and Drug Administration told the Indianapolis-based drugmaker in a "not approvable letter" that it needs more information on the medicine's major side effect, excessive sleepiness, the Indianapolis drugmaker announced today.
The long-acting Zyprexa is intended to treat schizophrenia in patients that might struggle to take the daily pill form of Zyprexa.
Excessive sleepiness, or sedation, occurred in about 1 percent of the patients tested with the long-acting, injectible Zyprexa. Pharmaceutical analysts thought the drug would be approved with a warning on its label about sedation.
However, a new case of sedation occurred shortly before Feb. 6, the day Lilly fielded questions from an FDA advisory panel of scientists about severe sedation. The most recent case occurred more than three hours after the patient was injected; previous cases of sedation had occurred sooner after injection.
Even though the panel voted that this version of Zyprexa could be approved, the FDA cited the most recent case of sedation in its letter to Lilly.
"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, Lilly's vice president of U.S. regulatory affairs.