FDA Rejects Lilly's New Zyprexa Form
Posted by Administrator (admin) on Feb 28 2008 at 5:15 PM
Zyprexa >>

The Food and Drug Administration didn’t approve a new injection form of the schizophrenia treatment Zyprexa introduced by Eli Lilly.

Eli Lilly introduced Zyprexa in 1996. Zyprexa is currently taken in tablet form or short-term using an intramuscular injection. Lilly was trying to get approval for a long-acting injection that combined Zyprexa with a pamoate salt for producing an extended delivery of the drug for up to four weeks.

FDA says they require detailed information for having a better understanding regarding the risk and cause of excessive sedation, which was reported in about 1% of the patients in clinical trials.

Dr. Jennifer Stotka, Lilly's vice president of U.S. Regulatory Affairs, expressed disappointment in FDA’s decision. Shares of Lilly were 1.9% down Thursday. (Eli Lilly is one of the Nifty Fifty stocks that propelled the late 20th century bull market).

A New York Times article published on December 17, 2006 says that Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its top-selling drug for schizophrenia. The main reference for this report was internal Lilly documents and e-mail messages among top company managers. These documents and e-mail messages were soon made publicly available as a location hidden TOR (The Onion Router) service, and then made available on the World Wide Web. But, in January 2007, Eli Lilly got a temporary restraining order from a US District Court to stop the public exposure or downloading of Eli Lilly documents about Zyprexa. After this, US-based websites removed the documents, however, they are still available at many sites outside the US. The main health risk associated to Zyprexa is diabetes due to its obesity and tendency to increase blood sugar. Zyprexa is Lilly’s best-selling medication, with sales of $4.2 billion last year.