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As a subscriber you can listen to articles at work, in the car, or while you work out. Subscribe NowA stock analyst says Eli Lilly and Co’s potential blockbuster drug prasugrel could face another Food and Drug Administration delay, Bloomberg News reported this morning.
The experimental blood thinner may not receive U.S. action until the second quarter after regulators said they made a “mistake” removing a critic of the drug from an advisory panel at the company’s urging, Bloomberg said.
The FDA removed panel member Sanjay Kaul after Lilly complained about research reports written by Kaul questioning prasugrel’s effectiveness and safety, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, told Bloomberg. The FDA removed him because they feared he might be biased, she said.
Jon LeCroy, an analyst with Nataxis Bleichroeder in New York, said the controversy could delay FDA action until the second quarter.
The advisory panel backed prasugrel’s approval 9-0 on Feb. 3 after advisers downplayed potential risks of bleeding and cancer, LeCroy said.
LeCroy described the meeting as a “love fest,” according to Bloomberg, and said in a report today that the FDA may add stricter label warnings than those recommended by the advisory panel that would “significantly slow the drug’s uptake.”
Kaul is director of a heart research laboratory at Cedars-Sinai Medical Center in Los Angeles.
“We were well prepared to answer any and all questions from the panel, regardless of who the members were,” Tamara Hull, a Lilly spokeswoman, said in an e-mail to Bloomberg today. “Panel membership is at the sole discretion of the FDA. We made the FDA aware that Dr. Kaul had previously published abstracts and made many public statements regarding prasugrel.”
Prasugrel, if approved in the United States, could take as much as 20 percent of market share from Plavix, which brought in $8.1 billion in 2007 for Bristol-Myers Squibb Co. and Sanofi-Aventis SA.
European regulators yesterday approved the drug to be sold under the name Efient.
Lilly will split revenue from the drug with Tokyo-based Daiichi Sankyo Co.
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