Glaxo Wins Approval for New AIDS Drug Despite Serious Risks

Important note: Information in this article was accurate in 1998. The state of the art may have changed since the publication date.

Glaxo Wins Approval for New AIDS Drug Despite Serious Risks

Wall Street Journal (12/21/98) P. B8

Glaxo Wellcome's newest AIDS drug, Ziagen, was approved for marketing by the Food and Drug Administration Thursday, even though clinical trials showed that about 5 percent of patients experienced significant, and in some cases, fatal side effects, including fever, nausea, abdominal pain, low blood pressure, and an enlarged liver. Despite the potential drawbacks, the FDA approved Ziagen because it is used to treat a life-threatening disease and may allow some patients to discontinue the use of drug "cocktails" that are the standard in AIDS treatment today. While many patients currently take as many as 20 pills a day, patients who can tolerate Ziagen in combination with another AIDS drug, such as Glaxo's Combivir, would have to only take about four pills a day. Ziagen, a nucleoside analogue reverse transcriptase inhibitor, is the fourth AIDS drug Glaxo has developed.

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