MONDAY, June 26 (HealthDay News) -- The U.S. Food and Drug Administration has approved darunavir (Prezista), a new protease inhibitor for use in treating HIV-infected adults who have not responded to other antiretroviral drugs. The drug is approved for co-administration with a low dose of ritonavir (as well as other anti-HIV agents), which increases the concentration of Prezista in the patient's system by slowing its absorption.
The drug is manufactured for Tibotec, Inc., by JOLL in Gurabo, Puerto Rico. The approval was based on the results of two studies that compared the Prezista-ritonavir combination with other protease inhibitor drug-cocktail therapies that include ritonavir. The studies tested the drug on patients who had already used HIV treatments and the drug's safety and efficacy has not been established in those who have not been previously treated, or in children.
The drug was given accelerated approval on the terms that the manufacturer verifies and describes the drug's clinical benefits through post-marketing trials. The manufacturer has also made a commitment to other trials, including pediatric trials and trials for patients with liver impairment.
"This drug is not a cure, but when combined with other standard therapies, it presents one more major step in our effort to help patients combat the effects of the disease," said Andrew C. von Eschenbach, M.D., acting commissioner of Food and Drugs in a statement.
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