EC suspends Viracept's marketing license

The European Commission has suspended the marketing authorization for Swiss drug major Roche's HIV protease inhibitor Viracept (nelfinavir). Two months ago, batches of the antiretroviral medicine, which is used in combination with other antivirals to treat adults, adolescents and children over 3 years of age with HIV-1, were recalled across Europe after it was found they were contaminated with the genotoxic substance ethyl mesilate (Marketletter June 11).

The decision is based on scientific conclusions of the European Medicines Agency (EMEA). The judgement follows consultation with European Union member states and can only be lifted by a further decision of the EC, after the EMEA's assessment of new data. Medicinal products can only be sold in the European Union after receiving a marketing authorization based on an assessment of their quality, safety and efficacy.

Viracept was approved in 1998. In early June 2007, to ensure the immediate suspension of use of the product, Roche immediately recalled all packs of the HIV drug on the Community market and informed prescribing doctors about the incident. All packs of Viracept available on the market were recalled, including those that patients may have had at home.