Eli Lilly says FDA has all Zyprexa data

Thu Apr 26, 2007 10:33am EDT
 
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COPENHAGEN, April 26 (Reuters) - Eli Lilly and Co. (LLY.N) said on Thursday it was working closely with the U.S. Food and Drug Administration and had provided the agency with all data on the side effects of its antipsychotic drug Zyprexa.

On Wednesday, the New York Times reported the FDA is examining whether Lilly gave it accurate data about the side effects of Zyprexa.

Angel Perez-Agenjo, Eli Lilly director for Denmark and Iceland, said the side-effects of Zyprexa had been reported extensively and that the FDA had been provided with all the data.

"We are working very closely with the FDA on Zyprexa as we are doing with any other product," he told Reuters in connection with the launch of Lilly's Byetta type 2 diabetes drug.

The Times reported the FDA had questions about a Lilly document from February 2000 in which the drug company found that patients taking Zyprexa in clinical trials were three and a half times as likely to develop high blood sugar as those who did not take it.

"We remain very confident of the efficacy and advantages of the product," Perez-Agenjo said.

Demand for the drug has waned in the United States amid concerns about its tendency to cause weight gains.

 

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