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By Peter Loftus Of DOW JONES NEWSWIRES The U.S. Food and Drug Administration has declined to approve Eli Lilly & Co.'s (LLY) application to market a long-acting formulation of its antipsychotic Zyprexa, and has asked Lilly to submit a plan to ensure patient safety.
Lilly received a "complete response" letter from the regulator in December, according to an email that Lilly sent some analysts this week. Lilly Chief Executive John Lechleiter publicly disclosed the FDA letter at a Goldman Sachs investor conference in New York Wednesday.
Such letters typically mean the FDA isn't yet ready to approve a proposed drug. In Lilly's case, the FDA isn't requiring any additional clinical trials for the drug, according to Lilly's email, but rather wants Lilly to firm up a "risk evaluation and mitigation strategy." Such plans are generally designed to manage a known or potential serious risk associated with a drug, and can include medication guides, patient package inserts and other measures.
Currently, Zyprexa is usually given as a once-daily tablet to treat schizophrenia and bipolar disorder. The drug is a blockbuster, having generated $3.5 billion in sales for the first nine months of 2008.
The long-acting formulation would be injected once every four weeks. The product was approved in Europe last year under the brand Zypadhera. Analysts see more modest sales for the long-acting formulation, with Leerink Swann predicting annual sales of $125 million in 2011.
In February 2008, the FDA rejected Lilly's application for long-acting Zyprexa, saying it needed more information to better understand the risk and cause of excessive sedation events that were observed in about 1% of patients in clinical trials. An FDA advisory committee had previously concluded the drug would be safe and effective as long as doctors and patients were informed about the sedation risk.
Lilly submitted a formal response to the FDA's rejection last year. Following the complete response letter, Lilly plans to have discussions with the FDA and hopes to "get to the finish line," Lechleiter said.
Lilly shares fell 95 cents, or 2.4%, to $38.62.
-By Peter Loftus, Dow Jones Newswires; 215-656-8289; peter.loftus@dowjones.com
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Publié le 07 janvier 2009 Copyright © 2009 Dowjones