FOSTER CITY, Calif. -- Gilead Sciences, Inc. today announced that the European Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), has recommended granting a Marketing Authorization for Truvada(TM) (emtricitabine and tenofovir disoproxil fumarate) in the 25 member states of the European Union. The European Commission generally follows the CHMP recommendation and grants a final Marketing Authorization within a few months following a positive recommendation. Truvada combines Emtriva(R) (emtricitabine) and Viread(R) (tenofovir disoproxil fumarate) in one tablet taken once a day in combination with other antiretroviral agents.
The CHMP recommended indication for Truvada is for the treatment of HIV-infected adults in combination with other antiretroviral agents. This indication is based on the demonstration of the benefit of the combination of emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy in treatment-naive patients. As Truvada contains emtricitabine and tenofovir disoproxil fumarate, the guidance for physicians in the Truvada Summary of Product Characteristics (SmPC) is consistent with the guidance in the SmPC of Emtriva and Viread.
"For many patients, combination therapy can mean adhering to drug regimens that involve multiple daily pills with dosing requirements that vary," said Brian Gazzard, MD, clinical research director, Chelsea and Westminster Hospital, London. "Truvada joins two of the drugs needed for triple-drug therapy into a single once-a-day tablet, making it an important new treatment option for patients, who must take a combination of drugs to combat the virus."
Gilead submitted a Marketing Authorization Application (MAA) for Truvada on March 12, 2004 under the centralized procedure. The positive opinion for Truvada is the fourth positive recommendation Gilead has received from the Committee for an antiviral treatment in three years.
"We are pleased to receive a positive opinion from the CHMP for Truvada," said John C. Martin, PhD, president and CEO of Gilead Sciences. "We look forward to our continued work with the EMEA to make this combination product available to people living with HIV/AIDS throughout Europe."
The U.S. Food and Drug Administration (FDA) granted marketing approval to Truvada in the United States on August 2, 2004. The U.S. Department of Health and Human Services (DHHS) Guidelines for the Use of Antiretroviral Agents recommend Truvada's component drugs, Viread and Emtriva, as a first line dual nucleoside reverse transcriptase inhibitor (NRTI) backbone in combination with a non-nucleoside reverse transcriptase inhibitor (NNRTI) for adults infected with HIV.
Source: Gilead Sciences, Inc.