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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 AdultsBristol-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. About Reyataz (atazanavir) Reyataz, co-administered with low dose ritonavir, is indicated in the EU for the treatment of HIV-infected adults and pediatric patients 6 years of age and older in combination with other antiretroviral medicinal products. Use of Reyataz in treatment-experienced patients should be based on individual viral resistance testing and the patient's treatment history. For more information, please see the Reyataz Summary of Product Characteristics at www.ema.europa.eu. About Bristol-Myers Squibb in HIV For more than 20 years, Bristol-Myers Squibb has focused on delivering innovative medicines to help meet the needs of patients living with HIV-1. Our goal is to help individuals living with HIV to live longer and healthier lives by achieving and maintaining viral suppression and addressing the challenges of treatment resistance. We are investigating new ways to attack the HIV virus, and studies are ongoing for innovative treatments including an HIV-1 attachment inhibitor (BMS-663068) and an HIV-1 maturation inhibitor (BMS-955176). Important Safety Information (ISI (News - Alert)) for Evotaz and Reyataz in the U.S. The following ISI is based on information from U.S. Prescribing Informatin for Evotaz and Reyataz. Please consult the full Prescribing Information for all labeled safety information. INDICATIONS for EvotazTM (atazanavir and cobicistat) and Reyataz® (atazanavir) EVOTAZ is a fixed dose combination of atazanavir and cobicistat, and is indicated for use with other antiretroviral agents for the treatment of HIV-1 infection in adults. REYATAZ is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults, and for patients 3 months and older weighing at least 10 kg. LIMITATIONS OF USE
IMPORTANT SAFETY INFORMATION for EVOTAZ and REYATAZ CONTRAINDICATIONS EVOTAZ and REYATAZ are contraindicated:
WARNINGS AND PRECAUTIONS The following Warnings and Precautions are associated with EVOTAZ (atazanavir and cobicistat) and REYATAZ (atazanavir):
EVOTAZ (atazanavir and cobicistat): ADDITIONAL WARNINGS AND PRECAUTIONS
REYATAZ: ADDITIONAL WARNINGS AND PRECAUTIONS
MOST COMMON MODERATE OR SEVERE ADVERSE REACTIONS EVOTAZ (atazanavir and cobicistat):
REYATAZ (atazanavir), regardless of causality:
DRUG INTERACTIONS EVOTAZ: Coadministration of EVOTAZ and the following drugs is not recommended
REYATAZ: Coadministration of REYATAZ and the following drugs is not recommended
See Table 5 of the EVOTAZ Full Prescribing Information, and Table 16 of the REYATAZ Full Prescribing Information for additional established and potentially significant Drug Interactions, and related dose modification recommendations. EVOTAZ and REYATAZ: Use in Renal Impairment
Please click here for the EVOTAZ full prescribing information Please click here for the REYATAZ full prescribing information *From U.S. Prescribing Information. EU SmPC may differ. About Bristol-Myers Squibb Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit http://www.bms.com or follow us on Twitter (News - Alert) at http://twitter.com/bmsnews. Bristol-Myers Squibb Forward Looking Statement This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that Evotaz will become a commercially successful product. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Tybost® is a registered trademark of Gilead Sciences, Inc.
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