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US approval for once daily abacavir/3TC and tenofovir/FTC pills
Keith Alcorn, Tuesday, August 03, 2004
The US Food and Drug Administration announced Monday that it has approved two once daily combination tablets manufactured by Glaxo SmithKline and Gilead.

The Glaxo SmithKline product is a combination of abacavir (600mg) and 3TC (lamivudine, 300mg) dosed once daily, and will be marketed as Epzicom in the United States. Epzicom approval is based on the results of a clinical trial which showed that each drug dosed once daily as a separate tablet was therapeutically equivalent to twice daily dosing.

The Gilead product is a combination of tenofovir (300mg) and FTC (emtricitabine, 200mg) dosed once daily, and will be marketed as Truvada worldwide. Truvada approval is based on bioequivalence studies of the constituent products and on efficacy studies of tenofovir and 3TC. 3TC is regarded by the FDA as sufficiently similar to FTC that it can be treated as a substitute for the purposes of approval.

The approval is likely to signal fierce new competition in the market for first-line HIV treatment. Gilead Sciences will present the results of a study comparing the effectiveness of once daily Truvada with twice daily Combivir within the next few months, and manufacturers are increasingly keen to promote the benefits of once daily treatment.

Both products are likely to be licensed in the European Union within the next six months.

Truvada is the first product to be approved by the FDA under new regulations that offer fast track review to fixed dose products for use in developing countries. Gilead Sciences announced yesterday that, in a bid to reduce the risk of product diversion from developing countries, the form of Truvada that will be available in 68 countries which currently qualify for the company’s no-profit distribution scheme will look different from the US version.

The US version of Truvada will be a dark blue capsule-shaped tablet. In developing countries where it is supplied under the no-profit scheme Truvada will be sold as a light blue capsule-shaped tablet.

All products are licensed for use in combination with other antiretroviral agents and should not be used in combination with any of the individual constituent products. For example, Epzicom should not be combined with Ziagen (abacavir) or with Combivir (zidovudine/lamivudine).