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Bristol-Myers’ Evotaz gets FDA approval for HIV-1 treatment in adults

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb's Evotaz tablets in combination with other antiretroviral agents to treat HIV-1 infection in adults.

Bristol Myers Squibb Pharmaceutical Research Institute

The once-daily Evotaz is a combination of the protease inhibitor atazanavir, marketed as Reyataz (atazanavir 200mg/300mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.

According to the company, the approval provides patients living with HIV a new treatment option that delivers proven suppression (HIV-1 RNA <50 copies/mL, 85% Evotaz arm; 87% Reyataz/ritonavir arm) through 48 weeks.

Bristol-Myers Squibb head of Worldwide Markets Murdo Gordon said: "We are pleased to provide physicians and patients with an important new option to treat HIV; atazanavir with cobicistat delivers sustained efficacy and safety through 48 weeks, as demonstrated through its rigorous clinical development plan, including a head-to-head Phase III trial.

"Evotaz increases the possibility of providing HIV suppression by combining reduced pill burden with a low rate of virologic failure (6% Evotaz arm; 4% Reyataz/ritonavir arm) and zero protease inhibitor mutations."

The approval is based on data from a randomized, double-blind Phase III trial, which involved a total of 692 people.

The trial evaluated the efficacy and safety of Reyataz 300mg with cobicistat 150mg (the components of Evotaz) compared to Reyataz 300mg with ritonavir 100mg (Reyataz/ritonavir), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults.

The company said that in the study, zero protease inhibitor resistance was detected through 48 weeks.

In 2011, BMS entered into licensing agreement with Gilead to develop and commercialize once-daily, fixed-dose combination product of atazanavir and cobicistat, now named Evotaz.


Image: BMS Pharmaceutical Pharmaceutical Research Institute on Reeds Lane, Moreton responsible for the discovery and development of new medicines. Photo: courtesy of Sue Adair.