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FDA Rejects New Form of Lilly's Zyprexa

The company wants to get clearance for a long-acting injection that combines Zyprexa with a pamoate salt.
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Eli Lilly

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received a not approvable letter from the Food and Drug Administration for a new injection form of the schizophrenia treatment Zyprexa.

Shares of Lilly were down 1.9% at $50.85 Thursday.

Zyprexa, introduced in 1996, is currently taken in tablet form or short-term via an intramuscular injection. Lilly was hoping to get clearance for a long-acting injection that combined Zyprexa with a pamoate salt in order to produce an extended delivery of the drug for up to four weeks.

In its letter, the FDA said it needs more information to better understand the risk and cause of excessive sedation that was reported in about 1% of the patients in clinical trials.

An advisory committee to the agency discussed those findings at a hearing earlier this month, but voted that there were circumstances under which the Zyprexa injection would be acceptably safe and effective in adults.

However, the FDA cited a new case of excessive sedation that occurred shortly before the hearing. All of the patients who experienced the unwanted side effect 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, Lilly's vice president of U.S. Regulatory Affairs. "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."

This article was written by a staff member of