Tenofovir European licence extended to include first-line therapy

1 July 2003. Related: Antiretrovirals.

On 27 May 2003 the European Medicines Evaluation Agency granted approval to expand the indication for tenofovir (Viread) to include the drug’s use in treatment-naïve HIV patients in Europe.

The Committee for Proprietary Medicinal Products (CPMP), the scientific committee of the EMEA, issued a positive opinion to expand the indication for tenofovir in February 2003. The Commission’s decision is based on 48-week results from Gilead’s Study 903 in 600 treatment-naïve patients infected with HIV, including patients with a high viral load (>100,000 copies/mL). [See HTB Jan/Feb 2003]

Tenofovir was first authorised for sale in the European Union in February 2002 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients experiencing early virological failure.

Source: Gilead Sciences press release

EMEA documents:
http://www.ema.europa.eu/humandocs/Humans/EPAR/viread/viread.htm

Gilead press release:
http://www.gilead.com/wt/sec/pr_1053732734