FDA Rejects J&J Leukemia Drug
The Food and Drug Administration on Thursday rejected an application by Johnson & Johnson (JNJ) for a new drug to treat a form of blood and bone marrow cancer called acute myeloid leukemia.
The rejection wasn't a surprise; an FDA advisory committee voted 7-4 against the drug, Zarnestra, last month, saying that J&J hadn't done enough research. J&J's application was based on data from just one phase II clinical trial. The FDA usually requires three sets of clinical trials, with phase III being the largest and most comprehensive test of a drug's safety and efficacy.
J&J, in a prepared statement, says it "remains committed" to developing the drug and adds that it is studying the FDA rejection letter so it can "determine appropriate next steps." The company didn't disclose the reasons why the FDA rejected the application.
J&J was seeking FDA approval for treating elderly patients for whom ordinary chemotherapy isn't appropriate. J&J says acute myeloid leukemia will strike nearly 12,000 Americans this year.J&J's stock lost 71 cents, or 1.1%, to $64.99.
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