Bristol-Myers’ Evotaz gets European approval to treat HIV-1 infection
Bristol-Myers Squibb has received approval from the European Commission for Evotaz, a fixed-dose combination of atazanavir and cobicistat, to treat HIV-1 Infection in adults.
Evotaz (atazanavir 300mg and cobicistat 150mg) tablets are approved for use in combination with other antiretroviral agents to treat HIV-1 infected adults without known mutations associated with resistance to atazanavir.
Co-formulated to be one pill, once-daily, Evotaz combines the protease inhibitor atazanavir, which is marketed as Reyataz capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences as Tybost.
The approval is based on data from a Phase III clinical trial in which Reyataz and cobicistat combination showed virologic failure rates as low as 6% at 48 weeks and 8% at 144 weeks.
The marketing authorization follows a positive opinion by the EMA’s Committee for Medicinal Products for Human Use (CHMP) in May 2015, while the drug was approved by the US Food and Drug Administration (FDA) in January this year.
The EC approval allows for the marketing of Evotaz in all 28 Member States of the EU and offers patients living with HIV a new treatment option that delivers proven suppression through 144 weeks.
Bristol-Myers Squibb Worldwide Markets head Murdo Gordon said: “HIV remains a significant public health concern throughout the world, and the increase in new infections in recent years in Europe means that it is more important than ever to continue to deliver 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, and we are pleased to bring it to physicians and patients in the EU.”