Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Important note: Information in this article was accurate in 1999. The state of the art may have changed since the publication date.
Reuters NewMedia - Tuesday October 5, 1999
Lisa Richwine
The FDA, in a warning letter released Tuesday, said Seattle-based Immunex made the statements in a press release issued May 3.
The press release said a clinical trial showed Leukine helped keep levels of HIV, the virus that causes AIDS, suppressed and allowed patients to take antiviral drug cocktails longer without developing resistance.
The press release "contains representations and suggestions that are false and misleading," wrote Steven Masiello, a top official in the agency's Center for Biologics Evaluation and Research.
An Immunex spokeswoman said on Tuesday the company had stopped distributing the press release and removed it from its Web site.
"We consider the matter closed at this time," spokeswoman Cathy Keck Anderson said.
Keck Anderson said the press release "describes data presented at a medical meeting. It describes factual data." She declined to discuss whether Immunex agreed with the FDA's charges.
Already approved to treat certain cancers, Leukine generated second-quarter net sales of $16.6 million, making it Seattle-based biotechnology company's second-best-selling product behind arthritis drug Enbrel. Enbrel's sales were $86.9 million.
American Home Products Corp. (NYSE:AHP - news) owns a majority stake in Immunex, which has been studying Leukine as a possible AIDS therapy since 1996. FDA objected to Immunex's statements in the May press release that Leukine, known generically as sargramostim, helped keep HIV suppressed in a Phase III clinical trial.
Investigators reached conclusions based on unblinded data, Masiello wrote in the letter, which was sent Aug. 23 and released to reporters Tuesday. Blinding prevents investigators or subjects from knowing the hypotheses or conditions being tested so results can be analyzed objectively.
"Consequently, any representations or claims regarding an effect upon change in antiviral therapy and incidence of all infections are not valid," Masiello wrote.
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