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The Medicines Company Announces Positive Top- Line Results for Phase 3 TANGO 1 Clinical Trial of CARBAVANCE

Shanghai Biopharmaleader Co.,Ltd | Updated: Jun 28, 2016

CARBAVANCE (meropenem-vaborbactam) met both FDA and EMA pre-specified primary endpoints in patients with complicated urinary tract infections (cUTI)
CARBAVANCE demonstrated statistical superiority over piperacillin-tazobactam, with overall success in 98.4% of treated patients, using FDA primary endpoint
CARBAVANCE safety comparable to piperacillin-tazobactam
TANGO 1 clinical data will support global regulatory submissions
The Company expects to submit a New Drug Application (NDA) to the FDA in early 2017
FDA has designated CARBAVANCE as a Qualified Infectious Disease Product (QIDP), as authorized under the GAIN Act, and granted Fast Track status
CARBAVANCE development program targets urgent and growing global threat of deadly gram-negative superbugs referred to as carbapenem-resistant Enterobacteriaceae (CRE)
The Company will host a conference call and audio webcast at 8:30 a.m., EDT, today
PARSIPPANY, NJ, USA I June 27, 2016 I The Medicines Company (NASDAQ:MDCO) today announced that its investigational antibiotic, CARBAVANCE® (meropenem-vaborbactam), met both FDA and EMA pre-specified primary endpoints in the Phase 3 TANGO 1 clinical trial in patients with cUTI. CARBAVANCE also demonstrated statistical superiority over piperacillin-tazobactam, with overall success in 98.4% of patients treated with CARBAVANCE, using the FDA primary endpoint. CARBAVANCE was well tolerated in the trial. The Company will present the complete results of TANGO 1 at an upcoming infectious disease conference.

“The results of TANGO 1 are compelling,” said Jeff Loutit, MBChB, Vice President and Chief Medical Officer of the Infectious Disease Group of The Medicines Company, who led the study. “Clinical and microbiological responses with CARBAVANCE in TANGO 1 were among the highest of clinical trials recently conducted with new antimicrobial agents. The demonstration of superiority with CARBAVANCE treatment over piperacillin-tazobactam in the FDA primary endpoint and the robust effects in other endpoints demonstrates the potential gains we can make clinically in the treatment of gram-negative infections. We believe that TANGO 1 provides the pivotal clinical data necessary for the submission of an NDA with the U.S. Food and Drug Administration (FDA) and a marketing authorization application (MAA) with the European Medicines Agency (EMA).”

Keith Kaye M.D., MPH, Corporate Vice President of Quality, Infection Prevention and Antimicrobial Stewardship at Detroit Medical Center said, “The threat of antibiotic resistance, particularly resistance to carbapenems, is growing rapidly here in the U.S. and around the world. CRE infections are one of the deadliest, with mortality reaching 40%. The U.S. Centers for Disease Control and Prevention (CDC) considers CRE as one of the top three most urgent drug-resistant infectious disease threats and the only one of the top three that causes systemic infections. The need for antimicrobials capable of effectively treating CRE and other resistant organisms is exceedingly high. The data from the CARBAVANCE development program overall may provide physicians with encouragement that new and effective treatment options are on the way.”

Michael N. Dudley, PharmD, Senior Vice President, Head of R&D and Co-Leader of the Infectious Disease Group of The Medicines Company, said, “We are grateful to all of the patients and physicians who participated in TANGO 1. We congratulate them and our CARBAVANCE team, which discovered and advanced a new chemical entity from the chemist’s bench in our laboratories through the successful completion of a pivotal Phase 3 trial with exceptional speed. The rapid development of CARBAVANCE and the success of TANGO 1 were significantly aided by our collaboration with the Biomedical Advanced Research and Development Authority (BARDA). We are grateful to BARDA for its ongoing support as we continue to advance meropenem-vaborbactam. We expect to file an NDA with the FDA in early 2017.”

Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company, added, “We are delighted with the results from TANGO 1, which further evidence the strength of our product discovery and development capabilities and reflect our continuing commitment to and execution against our strategy to focus on the four potential blockbuster products in our development pipeline, including CARBAVANCE. Today’s announcement also demonstrates the compelling attributes of our Infectious Disease Group and the attractive value proposition it provides. We continue to aggressively drive the development of our other three investigational agents—our PCSK9 synthesis inhibitor for lowering LDL-c; our lipid modulating agent, MDCO-216, which contains ApoA1-Milano and is targeted at arterial plaque regression; and our IV anesthetic and sedation agent, ABP-700—and we look forward to important news flow regarding these potential blockbusters over the second half of 2016.”

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