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European Commission Approves Bristol-Myers Squibb's Evotaz (atazanavir and cobicistat fixed-dose combination) for the Treatment of HIV-1 Infection in Adults
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The European Commission approval is based upon Phase III clinical trial - Reyataz®(atazanavir) and cobicistat combination demonstrated virologic failure rates as low as 6% at 48 weeks and 8% at 144 weeks [HIV-1 RNA ≥50 copies/mL: 6% Reyataz/cobicistat arm and 4% Reyataz/ritonavir arm at 48 weeks; 8% Reyataz/cobicistat arm and 5% Reyataz/ritonavir arm at 144 weeks]
Reyataz/cobicistat safety was demonstrated through 144 weeks in clinical trials
Link to full press release:
http://news.bms.com/press-release/european-commission-approves-nivolumab-bms-first-pd-1-immune-checkpoint-inhibitor-euro
Thursday, July 16, 2015
"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"
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Evotaz (atazanavir 300 mg and cobicistat 150 mg) tablets in combination with other antiretroviral agents for the treatment of HIV-1 infected adults without known mutations associated with resistance to atazanavir. Coformulated to be one pill, once-daily, Evotaz combines the protease inhibitor atazanavir, which is marketed as Reyataz (atazanavir) capsules, and cobicistat, a pharmacokinetic enhancer marketed as Tybost® by Gilead Sciences, Inc. Today's approval allows for the marketing of Evotaz in all 28 Member States of the European Union (EU) and offers patients living with HIV an innovative treatment option that delivers proven suppression through 144 weeks. The marketing authorization follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in May 2015. The U.S. Food and Drug Administration (FDA) approved Evotaz in the United States in January 2015.
Evotaz is contraindicated in patients with previously demonstrated clinically significant hypersensitivity to the active substances or to any of the excipients of Evotaz, in combination with certain drugs, and in patients with moderate to severe hepatic impairment. Evotaz and Reyataz do not cure HIV-1 infection or AIDS.
There are 2.2 million people living with HIV in the European region, according to recent estimates from UNAIDS and WHO, and between 2004 and 2013, more than 300,000 people were newly infected. Only one-third of diagnosed patients (35%) in the eastern European region were receiving antiretroviral therapy in 2012, a number that is significantly below the 80% coverage goal set by WHO for 2015. Virologic suppression, or the reduction of HIV viral load to undetectable amounts in the blood, is the goal of antiretroviral treatment in all patients.
"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," said Murdo Gordon, Head of Worldwide Markets, Bristol-Myers Squibb. "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."
Study Design
Evotaz is the first and only fixed-dose combination (FDC) of a protease inhibitor pharmacoenhanced by cobicistat that is supported by comparative Phase III trial data. The European Commission's approval is based on data from Gilead's Study 114, a randomized, double-blind clinical trial (N=692) evaluating the safety and efficacy of Reyataz 300 mg with cobicistat 150 mg (the components of Evotaz) (n=344) versus Reyataz 300 mg with ritonavir 100 mg (Reyataz/ritonavir) (n=348), another pharmacokinetic enhancing agent, in combination with emtricitabine/tenofovir disoproxil fumarate in treatment-naive adults. At 48 weeks, 85% of patients in the Reyataz/cobicistat arm achieved virologic success (HIV-1 RNA levels of <50 copies/mL) compared to 87% of patients in the Reyataz/ritonavir arm. Low rates of virologic failure (HIV-1 RNA ≥50 copies/mL: 6% Reyataz/cobicistat arm; 4% Reyataz/ritonavir arm) were also observed at 48 weeks. The long-term data at week 144 also confirmed these results, with virologic success and failure rates of 72% and 8%, respectively, in the Reyataz/cobicistat arm, and 74% and 5%, respectively, in the Reyataz/ritonavir arm. Virologic failure, which occurs when therapies are unable to completely suppress HIV, may be caused in part by drug resistance. Limited data are available on the development of resistance to Reyataz/cobicistat. However, in the clinical trial, no patients taking Reyataz/cobicistat who had virologic failure developed protease inhibitor resistance through 48 weeks. Specifically, zero patients developed tenofovir-associated resistance K65R, and two patients developed emtricitabine resistance M184V. In the Reyataz/ritonavir arm, zero resistance was observed.
"The clinical efficacy demonstrated by Reyataz/cobicistat - in one pill rather than two as with ritonavir-boosted Reyataz - is significant for protecting against drug resistance and helping to increase the potential for virologic suppression," said Douglas Manion, M.D., Head of Specialty Development, Bristol-Myers Squibb. "Preventing resistance is a paramount consideration for management of HIV, and a critical success factor in suppressing the disease."
Reyataz/cobicistat also demonstrated a safety profile comparable to Reyataz/ritonavir. The most common moderate to severe adverse events (AEs) in both treatment arms were jaundice, ocular iterus, and nausea. There were similar low rates of discontinuation due to AEs with Reyataz/cobicistat as compared to Reyataz/ritonavir at 48 weeks (6% and 7%, respectively). The Summary of Product Characteristics will be available at www.ema.europa.eu.
In October 2011, Bristol-Myers Squibb announced a licensing agreement with Gilead for the development and commercialization of a once-daily, fixed-dose combination product of atazanavir and cobicistat, now named Evotaz. Under the terms of the agreement, Bristol-Myers Squibb and its affiliates are responsible for the formulation, manufacturing, registration, distribution and commercialization of the Evotaz fixed-dose combination product worldwide. Gilead retains sole rights for the manufacture, development and commercialization of cobicistat as a stand-alone product and for use in combination with other agents.
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