Positive opinion for Atripla opens way for once daily HIV treatment

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion on the Marketing Authorisation Application for Atripla (efavirenz 600mg/emtricitabine 200mg/tenofovir disoproxil fumarate 300mg).

The CHMP's positive recommendation will be reviewed by the European Commission, which has the authority to approve medicinal products for use in the 27 countries of the EU. The companies expect the Commission to issue its decision on the marketing authorisation for Atripla towards the end of the year. Once granted by the European Commission, the drug would represent the first and only once-daily single tablet regimen for many HIV/AIDS patients in the EU.

The MAA for Atripla in the EU was filed jointly by Bristol-Myers Squibb, Merck Sharp & Dohme and Gilead Sciences through a three-way joint venture based in Ireland.

Efavirenz is marketed by Bristol-Myers Squibb under the tradename Sustiva in the US, Canada and six European countries (France, Germany, Republic of Ireland, Italy, Spain and the UK). In other territories, including all other EU countries, efavirenz is commercialised by MSD and is marketed in most of these countries under the tradename Stocrin. Emtricitabine and tenofovir disoproxil fumarate are commercialised by Gilead under the tradenames Emtriva and Viread respectively, and are commonly prescribed together as a once- daily, fixed-dose tablet, marketed under the tradename Truvada for use as part of combination therapy.

Atripla was approved by the US FDA in July 2006 and has since become the most-prescribed treatment regimen for patients starting HIV therapy in the US.

"Each of the components in Atripla has been shown to be effective and has a well-established tolerability profile in HIV patients," said Dr Brian Gazzard, clinical research director, Chelsea and Westminster Hospital, London. "This first one-pill-a-day treatment for HIV represents a simplification of dosing, which is important as patients remain on therapy longer."