HIV drug Atripla submitted to EMEA

USA-based drugmakers Gilead Sciences, Bristol-Myers Squibb and Merck & Co say they have completed the submission of a marketing authorization application to the European Medicines Agency (EMEA) requesting approval for the combination HIV therapy Atripla (efavirenz 600mg/emtricitabine 200mg tenofovir dioproxil fumarate 300mg). The MAA was filed jointly by the firms through a newly-established Irish joint venture.

The product, which is a once-daily, single-tablet regimen for the treatment of HIV-1 infection in adults, either alone or in combination with other antivirals, received approval from the US Food and Drug Administration earlier this year (Marketletter July 17).