Policy & Politics
FDA Expected to Approve Gilead, Bristol-Myers Squibb Once-a-Day Combination Antiretroviral Pill
July 10, 2006
FDA is expected as soon as this week to approve Gilead and Bristol-Myers Squibb's once daily antiretroviral treatment regimen that combines BMS' Sustiva and Gilead's Truvada into a single pill, the New York Times reports (Pollack, New York Times, 7/9). The two companies in December 2004 announced that they would collaborate with the aim of developing the single daily combination antiretroviral drug. Currently, antiretroviral treatment requires patients to take several pills daily, sometimes at specific times and under certain conditions. If approved, the once daily combination pill would be the first highly active antiretroviral treatment regimen available in a single, daily pill. The pill submitted for approval includes 200 milligrams of emticitabine and 300 milligrams of tenofovir -- the two generic antiretrovirals included in Truvada -- as well as 600 milligrams of Sustiva, known generically as efavirenz. The application asks that the combination be approved to treat HIV-1 infection in adults, according to the companies (Kaiser Daily HIV/AIDS Report, 4/28). The price and name of the drug has not yet been revealed, though officials at both companies suggest it might cost roughly the same as Sustiva and Truvada, which combined cost about $14,000 per person annually in the U.S., the Wall Street Journal reports. According to the Journal, FDA said it will expedite the approval applications for the combination drug in as little as two to six weeks (Hamilton, Wall Street Journal, 7/10). Sustiva and Truvada are the most widely prescribed antiretroviral treatment regimen in the U.S., and physicians and securities analysts predict that most people currently taking the drugs separately will switch to the new combination pill, according to the Times. It is less certain how many people taking other antiretroviral combinations will switch. Some people might be intolerant of the side effects caused by Sustiva and Truvada, and some already might have become resistant to one of the antiretrovirals in the new pill, the Times reports. The agency has until October to act but is expected to do so sooner, in part because the government has encouraged companies to collaborate to create simpler HIV/AIDS drugs, the Times reports (New York Times, 7/9).
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This article was provided by Henry J. Kaiser Family Foundation. It is a part of the publication Kaiser Daily HIV/AIDS Report. Visit the Kaiser Family Foundation's website to find out more about their activities, publications and services.