European Regulators Approve Gilead AIDS Drug

Patients who no longer respond to their AIDS drugs were given new hope on Thursday when European regulators approved Viread, a new antiviral treatment developed by Gilead, the US biotechnology company. Gilead said it expected to launch its AIDS drug in Europe early next year, following faster-than-expected approval by regulators. The European Medicines Evaluation Agency used new regulations for urgently needed treatments to approve the new medicine in 85 days, making it the fastest-ever approval in Europe.

Initial approval is restricted to HIV patients who no longer respond to other AIDS treatments because the virus has become resistant. Gilead hopes to widen the approval to include all HIV patients after completing extra clinical trials of the treatment. Patients who started taking treatments before triple therapy became standard are most at risk of resistance. Patients who do not take their drugs regularly are also at increased risk of developing resistance. Doctors usually switch patients to different treatments if resistant strains of the virus appear in their blood, but the number of treatments is limited, making approval of new drugs an urgent issue. The drug was approved by US regulators last month.

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