U.S. FDA APPROVAL OF PREZISTA™ ENABLES POTENT NEW HIV DRUG COMBINATION WITH FUZEON®

Story Summary:

The approval of a Ritonavir-boosted protease inhibitor (PI), Darunavir, by the U.S. Food and Drug Administration (FDA) will enable physicians and patients to create a potent new treatment combination with FUZEON® (enfuvirtide) for people living with drug-resistant HIV.

In pivotal clinical studies with Darunavir/R, up to two-thirds of patients with extensive prior exposure to anti-HIV drugs achieved undetectable levels of HIV when the drug was used in combination with FUZEON.

A product of Tibotec Pharmaceuticals Ltd., Darunavir, also known as TMC-114 and the trade name Prezista™, is a member of the PI class and is reported to be active against virus that has developed resistance to other PIs. First approved in 2003, FUZEON was co-developed by Roche and Trimeris, Inc.

The goal of therapy in extensively treatment-experienced patients, as defined by the Antiretroviral Treatment Guidelines from the U.S. Department of Health and Human Services (DHHS), has evolved over the last several years as newer boosted protease inhibitors, such as duranavir/r, have entered late-stage clinical trials and become available for use in combinations with FUZEON.