European CPMP gives positive opinion for European licensing of tenofovir DF

The European Union’s Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the European Medicines Evaluation Agency (EMEA), has recommended granting of the Marketing Authorisation for tenofovir disoproxil fumarate (Viread™) in the 15 member states of the European Union.

The European Commission will consider granting of the final Marketing Authorisation on the basis of the CPMP’s recommendation. Gilead anticipates the Marketing Authorisation will be granted in early 2002. Earlier this month, the U.S. Food and Drug Administration’s Antiviral Drugs Advisory Committee recommended the marketing approval of tenofovir DF in the United States.

Gilead submitted its Marketing Authorisation Application (MAA) for tenofovir DF for review under the centralized procedure on May 4, 2001. This application was granted an accelerated review by the CPMP because the product addresses an unmet medical need as defined in the recent CPMP “Points to Consider” document for the assessment of anti-HIV medicinal products. On the basis of the safety and efficacy data submitted for tenofovir DF, the committee has recommended the granting of a Marketing Authorisation under exceptional circumstances. The indication recommended by the CPMP is for tenofovir DF taken in combination with other antiretroviral agents in HIV-positive patients over 18 years of age experiencing early virological failure.

“There are increasing needs across Europe for treatments to combat HIV infection, particularly for individuals who have failed other therapy,” said Brian Gazzard, M.D., Chelsea and Westminster Hospital and Clinical Research Director, Imperial College, London. “The rapid review of the tenofovir DF application and issuance of a positive opinion by the CPMP is testament to the commitment of regulators in Europe to provide physicians and patients with new HIV treatments as quickly as possible.”

In addition to studies in treatment experienced patients, Viread is being evaluated in a treatment naive population in an ongoing clinical study (903) being conducted in Europe, South America and the U.S. This 96-week Phase III trial is designed to compare a treatment regimen of Viread, lamivudine (3TC) and efavirenz to a treatment regimen of stavudine (d4T), lamivudine and efavirenz in a blinded fashion in patients who have not previously received antiretroviral treatment. Enrolment in Study 903 was completed in January 2001 with 601 patients, and 48-week data will be available in the first half of 2002.

Expanded access program

More than 5,000 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. For more information regarding the tenofovir DF expanded access program or to request registration materials, physicians in Europe may call 33-1-44-90-34-46, those in Australia may call 800-806-112 and those in the United States and Canada may call 1-800-GILEAD-5.