The Food and Drug Administration’s Antiviral Advisory Committee has voted unanimously to approve the licensing of tenofovir in treatment-experienced individuals, but split nine to seven against approving the drug for use in treatment-naïve individuals. Although manufacturer Gilead will not have data from a head to head comparison with d4T in treatment-naïve patients until late 2002, sentiment was surprisingly strong among panel members (who are treating clinicians) that the drug would be useful, safe and as effective as existing therapies among those starting treatment.
The FDA will now consider the advice of the Advisory Committee and make a decision by November 1; Gilead hopes to launch tenofovir, with the brand name Viread, before the end of the year in the United States. The market for the drug has been estimated at $250 million in the first year alone in the US.
In Europe, tenofovir will be the subject of discussion at a meeting of the CPMP, the scientific committee of the European Medicines Evaluation Agency, in mid-October. If tenofovir is approved at this meeting, the drug could be available for prescription in the UK in January. It may take longer in other European countries where pricing negotiations will have to take place.
In the meantime, tenofovir is available through an expanded access programme for patients who cannot tolerate other nucleoside analogues or where it is impossible to asemble a viable anti-HIV combination without the drug, due to nucleoside analogue resistance. More than 450 individuals are already receiving tenofovir this way in the United Kingdom.
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