Tenofovir DF approved for marketing in European Union

Gilead Sciences Inc has announced that the European Medicines Evaluation Agency (EMEA) has granted the Marketing Authorisation for tenofovir disoproxil fumarate (Viread) in all 15 member states of the European Union.

Tenofovir DF is approved in Europe for use in combination with other antiretroviral agents for the treatment of human immunodeficiency virus (HIV) infection in patients who are experiencing early virological failure. This approval comes after the European Union’s Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion on tenofovir DF in October 2001. Gilead submitted its Marketing Authorisation Application (MAA) for tenofovir DF for review by the EMEA in May 2001.

Tenofovir DF is the first nucleotide reverse transcriptase inhibitor (NtRTI) approved for the treatment of HIV. The drug works by blocking reverse transcriptase, an enzyme crucial to the replication of HIV. As a nucleotide, tenofovir DF remains in cells for longer periods of time than many other antiretroviral agents, allowing for once-daily dosing. A key benefit of tenofovir DF is its ability to reduce the viral load in HIV-1 infected adult patients who have become resistant to other available HIV drugs.

“There are increasing needs across Europe for treatments to combat HIV infection, particularly for individuals who have failed other therapy,” commented Professor Brian Gazzard, Clinical Research Director, Chelsea and Westminster Hospital, Imperial College, London. “Clinical studies have highlighted tenofovir DF’s safety and tolerability, favourable resistance profile and potent antiviral activity. Additionally, the drug’s convenient once-daily dosing makes it an important new option for physicians and their patients with HIV infection.”

At the end of 2001, an estimated 560,000 people in Western Europe were living with HIV, with 30,000 people newly infected each year. As the HIV patient population grows and patients live longer, the need for optimal long-term antiretroviral therapy has intensified.

Tenofovir DF, which is dosed as one tablet once daily with a meal, will be available shortly in Europe following completion of local reimbursement approvals. Tenofovir DF was approved for marketing in the United States by the Food and Drug Administration (FDA) on October 26, 2001. Regulatory filings for the drug also have been completed in Australia and Canada and additional regulatory filings are planned in other countries in the coming months.

Expanded Access Program

Approximately 7,700 patients with advanced HIV infection have enrolled in tenofovir DF expanded access programs in Australia, Canada, France, Germany, Ireland, Italy, the Netherlands, Portugal, Spain, the United Kingdom and the United States. More than 4,000 patients have enrolled in Europe. For more information regarding the tenofovir DF expanded access program, physicians in Europe may call +33-1-44-90-34-46, those in Australia may call 800-806-112 and those in Canada may call 1-800-GILEAD-5. These programs will continue until the product is commercially available.