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FDA takes more time to review Lilly drug
Delay on Cymbalta, seen as a potential gold mine, isn't tied to suicide, firm says.

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Eli Lilly stock quote
Eli Lilly Fact File

June 25, 2004

The Food and Drug Administration has extended by three months its deadline to decide on Eli Lilly and Co.'s application to sell the potential blockbuster antidepressant Cymbalta.

The drug gained attention after the suicide of Traci Johnson, a healthy 19-year-old woman who took the drug during a Lilly clinical trial.

Lilly spokesman David Shaffer said the extension is not related to the Feb. 7 suicide at Lilly's Indianapolis clinic.

"It absolutely is not related to that (suicide)," Shaffer said. "We'd know what the subject is they're looking at right now, and that's not it."

Lilly is counting on Cymbalta, which analysts say could generate sales of more than $1 billion a year, to step into the gap left by its former No. 1 Prozac, an antidepressant that lost U.S. patent protection in 2001.

Under federal law, the FDA had until June 23 to act on the application. That's been extended to Sept. 23, though the FDA could give approval sooner, Lilly said Thursday.

FDA officials told Lilly the extension is needed to review "additional analysis we were asked to submit," Schaffer said. He wasn't specific on what additional materials were provided to regulators.

New antidepressants are being looked at more closely by the FDA, in part because of new data appearing to show that some antidepressants increased the risk of suicide, said Bert Hazlett, a stock analyst with SunTrust Robinson Humphrey in New York. "There is obviously additional scrutiny being attributed to the drugs in this class," Hazlett told Bloomberg News.

Lilly has said its investigation shows Cymbalta did not cause Johnson's suicide, though some family and friends have previously said they believe it did.

"We remain confident about the data we have submitted (to the FDA) and the safety and efficacy profile Cymbalta has demonstrated," John Lechleiter, executive vice president of pharmaceutical products and corporate development at Lilly, said in a statement.

Peggy Johnson, Traci Johnson's mother, said she had no comment on the FDA extension. "I wish they would just let my poor daughter Traci rest in peace," she said. The family's attorney, John Cordisco, said he had no comment.

Lilly applied for FDA approval in November 2001. Manufacturing problems cited by the FDA at Lilly manufacturing plants in Indianapolis contributed to earlier delays in approval.

Only Mexico has approved Cymbalta for sale, but Lilly hasn't yet put the drug on the market in Mexico, Shaffer said.

Lilly's stock price fell 41 cents a share Thursday, to $72.73. The FDA's extension of time was announced after Wall Street closed Thursday.

Call Star reporter Jeff Swiatek at (317) 444-6483.

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