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GLAXO's ETHANOLAMINE OLEATE IS BENEFICIAL FOR BLEEDING ESOPHAGEAL VARICES

Executive Summary

GLAXO's ETHANOLAMINE OLEATE IS BENEFICIAL FOR BLEEDING ESOPHAGEAL VARICES, but FDA's Gastro-Intestinal Drugs Advisory Committee was divided on an approval recommendation at its Dec. 2 meeting. The committee concurred that the injectable orphan drug was beneficial in treatment of initial bleeding and rebleeding of esophageal varices. In summarizing remarks, Committee Chairman Donald Wilson, MD, State University of New York/Downstate Medical Center, stated that the committee "has come down, more or less, is favor of [ethanolamine oleate] being approved for effective therapy for the acute bleeding of esophageal varices and rebleed." Seven committee members voted; four voted in favor of recommending approval, two voted against, and one abstained. The committee agreed the product does not improve survival rate. Glaxo VP-Product Development Peter Wise, MD, observed that in 1982 FDA announced in a Federal Register notice that there were sufficient published and unpublished data to invite an NDA submission for use of ethanolamine oleate, trademarked Ethamolin, in the treatment of bleeding esophageal varices. Wise said the agency subsequently contacted Glaxo and encouraged the company to submit an NDA, which it did in September 1984. Data on the agent includes 12 published studies and case report data from two U.S. investigators at the Mayo Clinic and Massachusetts General Hospital. Committee member Melvin Schapiro, MD, University of California/Los Angeles, said he would "have to recommend non-approval" based on the lack of data comparing the efficacy and toxicity of ethanolamine oleate with the two more commonly used sclerosing agents in the U.S., sodium tetradecyl sulfate and sodium morrhuate. Committee member James Butt, MD, Harry S. Truman Memorial Veterans Hospital, said he would recommend approval contingent on comparative studies being conducted. Committee member Bertram Fleshler, MD, Cleveland Clinic Foundation, concluded that ethanolamine oleate is better than having no treatment, and this fact "would force me to make a decision" for approval. However, Fleshler said he would feel more comfortable to defer the decision to FDA. He also requested the opportunity to re-examine the available data and suggested that FDA do the same. FDA Cardio-Renal Division Director Raymond Lipicky, MD, commented that the database fr ethanolamine oleate "doesn't come anywhere close as it now stands" to the agency's criteria to support efficacy of a drug. Lipicky stated: "The reasons I've heard people say that it does not need to come up to that criteria is the [bleeding esophageal varices] is a terrible disease, it's hard to study, that we can't really do controlled trials, and that on whole, the supporting data, which really hasn't been analyzed in any sensible way, is consistent with the controlled data." Noting that the committee's opinion "has not led to an overwhelmingly enthusiastic support" for the drug, Lipicky said he would see what information was available from the data for reanalysis.
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