CHMP recommends approval of Atripla for HIV-1

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for the combination HIV drug Atripla (efavirenz 600mg; emtricitabine 200mg; tenofovir disoproxil fumarate 300mg). The product, which was co-developed by USA-based companies Bristol-Myers Squibb and Gilead Sciences, and Merck Sharpe and Dohme, the UK subsidiary of Merck & Co, was approved by the US Food and Drug Administration for the treatment of HIV-1 infection last year (Marketletter July 17, 2006).

The CHMP's recommendation specifies that Atripla be used in the treatment of HIV-1 infected individuals who have demonstrated a minimum three months of virologic suppression, defined as less than 50 copies of viral RNA/ml, on their current medication. The committee added that the drug is not suitable for patients who have either experienced virologic failure while receiving any other antiretroviral therapies, or for those who have shown resistance to any of Atripla's components.

The firms welcomed the CHMP guidance and said that if, as is expected, the EMEA goes on to grant full approval, the drug will be the first once-daily, single-tablet HIV treatment to be available in Europe.