Fixed dose combination (FDC) of tenofovir/FTC/efavirenz (Atripla) filed in EU

On 9 October 2006, filing for the fixed-dose combination of tenofovir/FTC/efavirenz (Atripla) was submitted to the European regulatory authorities (Committee for Medicinal Products for Human Use (CHMP), subject to validation by the EMEA). It usually takes approximately 6 months from filing for the EMEA to approve a Marketing Authorisation Application, and for the drug to become commercially available.

This one-pill, once-daily formulation is the result of a collaboration between Gilead Sciences (manufacturers of tenofovir and FTC), Bristol-Myers Squibb, and Merck Sharp & Dohme (who hold marketing rights for efavirenz in different European countries).

The product contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs).