Bristol-Myers Squibb Company passes US FDA's approval for Evotaz tablets in combination with antiretroviral agents for HIV-1 infection in adults.
M2 EQUITYBITES-February 2, 2015-Bristol-Myers Squibb Company passes US FDA's approval for Evotaz tablets in combination with antiretroviral agents for HIV-1 infection in adults
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Medicine company Bristol-Myers Squibb Company (NYSE:BMY) disclosed on Wednesday the receipt of the US Food and Drug Administration's (FDA) approval for Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults.
The company said Evotaz is coformulated to be one pill, once-daily, combining the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir 200 mg/300 mg) capsules, and cobicistat, a pharmacokinetic enhancer marketed by Gilead Sciences.
According to the company, Evotaz is the first and only protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III trial data. The randomized, double-blind clinical trial evaluated the efficacy and safety of Reyataz 300 mg with cobicistat 150 mg (the components of Evotaz)versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults.
Patients had a baseline estimated CrCL >70mL/min, a mean baseline plasma HIV-1 RNA of 4.8 log10 copies/mL, and a mean baseline CD4+ cell count of 352 cells/mm, revealed the company .
This approval delivers proven suppression (HIV-1 RNA
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|Publication:||M2 EquityBites (EQB)|
|Date:||Feb 2, 2015|
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