European regulators have approved Bristol-Myers Squibb’s Evotaz pills in combination with other antiretroviral agents for the treatment of adult patients infected with HIV-1.
The once-daily therapy combines the protease inhibitor atazanavir, which BMS markets as Reyataz (atazanavir), and cobicistat, a pharmacokinetic enhancer sold by Gilead as Tybost.
Approval came on the back of Phase III data showing that the combination pill demonstrated virologic failure rates as low as 6% at 48 weeks and 8% at 144 weeks.
Around 2.2 million people are living with HIV in the European region, and between 2004 and 2013 more than 300,000 people were newly infected, highlighting the urgent need for new treatment options to help patients achieve virologic suppression.
“By combining reduced pill burden with a low rate of virologic failure and no protease inhibitor mutations, Evotaz increases the possibility of suppressing HIV,” the firm noted.
Evotaz was approved for use in the US back in January.