UPDATE - US panel backs Bristol-Myers anti-HIV drug
Tuesday May 13, 7:31 pm ET
By Lisa Richwine
GAITHERSBURG, Md., May 13 (Reuters) - A U.S. advisory panel on Tuesday unanimously urged approval of a Bristol-Myers Squibb (NYSE:BMY - News) HIV-fighting drug that may simplify treatment and spare patients a major side effect seen with some other medicines.
The Food and Drug Administration is expected to make a decision by June 20 on whether to approve Reyataz for use with other drugs to treat infection with the HIV virus that causes AIDS. The FDA usually follows its panels' advice.
Reyataz, an experimental drug in the class known as protease inhibitors, can simplify AIDS treatment because it can be taken as two pills once a day, said Dr. Steven Schnittman, Bristol-Myers' vice president for global development. Patients often have trouble sticking with complex schedules of multiple drugs to keep the virus at bay.
Another problem is that some HIV-fighting drugs are linked with raised cholesterol, sometimes requiring treatment with statins or other medicines. In clinical trials, Reyataz did not elevate cholesterol in patients undergoing HIV treatment for the first time, Schnittman said.
For patients previously treated with AIDS drug cocktails, some saw their levels of cholesterol and other blood fats fall with Reyataz treatment, Schnittman said.
Reyataz "is clearly active. We saw convincing data" in patients new to HIV treatment, said Dr. Roy Gulick, the panel's chairman and an associate professor of medicine at Weill Medical College of Cornell University.
Studies in patients previously treated with other medicines showed evidence of activity but the data was less convincing, Gulick said.
Mara Goldstein, an analyst for CIBC World Markets Corp., said many patients likely will use the new Bristol-Myers drug because of its convenient once-daily dosing and because of the advantage related to cholesterol and other blood fats.
"Its effectiveness is not that different from rival medicines, but its other advantages should lead to annual sales of up to $650 million," Goldstein said.
In clinical trials, many Reyataz patients experienced raised levels of a pigment called bilirubin that in some cases turned the skin yellow. Gulick said the panel felt that was an acceptable side effect. The effect was reversed if the drug was stopped, Bristol-Myers said.
Some panel members said the drug's label should caution doctors and patients about a possible effect on heart rhythms. The effect was manageable, and the rate was comparable to what is seen with other HIV drugs, Bristol-Myers said. |
