Atripla takes a key step towards European approval

Atripla, which provides potent anti-HIV therapy in one pill, once a day, has moved a key step closer to formal approval in Europe.

The European Medicine Agency’s Committee for Medicinal Products for Human Use has provided a positive opinion for Atripla, recommending that the drug receives marketing approval in the European Union.

Each film coated tablet of Atripla includes a combined fixed dose of efavirenz (Sustiva) 600mg, FTC (emtricitabine, Emtriva) 200g, and tenofovir (Viread), 245mg. This combination of drugs is recommended for first-line anti-HIV therapy in the treatment guidelines of the British HIV Association and is currently used as separate once-daily agents, with FTC and tenofovir being available in a combination pill, Truvada.

But the EMEA has only approved the use of Atripla by patients who have already achieved virological suppression to below 50 copies/ml (an undetectable viral load) on their current antiretroviral regimen for at least three months. Furthermore, patients must not have experienced virological failure with an earlier treatment combination or be known to have resistance to any of the drugs in Atripla.

The EMEA will publish further documentation explaining the thinking behind this licensing indication - which is stricter than the US product license - within the next few months.

Now that a positive scientific opinion has been received, formal marketing approval can be expected within the next few months. Atripla is already approved in the United States and Canada.