Merck Receives Positive CHMP Opinion by reason of Investigational Antibiotic ZERBAXA™ (Ceftolozane and Tazobactam)
Monday, July 27, 2015 8:30 am EDT
KENILWORTH, N.J.–(BUSINESS WIRE)–Merck (NYSE:MRK), known viewed like MSD outside the United States and Canada, today announced that the Committee against Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a unconditional opinion recommending approval of the investigational antibiotic ZERBAXA™ (ceftolozane and tazobactam) concerning the treatment of the following infections in adults: complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary parcel infections.
The CHMP positive opinion determination be reviewed by the European Commission. If the European Commission affirms the CHMP persuasion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, for the re~on that well as European Economic Area members, Iceland, Liechtenstein and Norway.
ZERBAXA (ceftolozane and tazobactam) conducive to injection (1.5 g) is ~y antibacterial combination product for intravenous inculcation consisting of the cephalosporin antibacterial mix with ~s ceftolozane sulfate and the beta-lactamase inhibitor tazobactam sodium.
ZERBAXA is approved in the United States and is indicated in ripened patients for the treatment of complicated urinary region infections (cUTI), including pyelonephritis, caused through the following Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, and Pseudomonas aeruginosa. ZERBAXA used in amalgamation with metronidazole is indicated in of mature age patients for the treatment of complicated intra-ventral infections (cIAI) caused by the following Gram-negative and Gram-overbearing microorganisms: Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Bacteroides fragilis, Streptococcus anginosus, Streptococcus constellatus, and Streptococcus salivarius.
To contract the development of drug-resistant bacteria and assert the effectiveness of ZERBAXA (ceftolozane and tazobactam) and other antibacterial drugs, ZERBAXA should subsist used only to treat infections that are proven or violently suspected to be caused by impressible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the abstraction of such data, local epidemiology and impressibility patterns may contribute to the experimental selection of therapy.
Important Safety Information not far from ZERBAXA
Patients with renal impairment: Decreased efficacy of ZERBAXA has been observed in patients with baseline CrCl of 30 to ≤50 mL/min. In a clinical assay, patients with cIAIs with CrCl ≥50 mL/min had a clinical corrective rate of 85.2% when treated with ZERBAXA plus metronidazole vs 87.9% when treated with meropenem. In the sort trial, patients with CrCl 30 to ≤50 mL/min had a clinical therapy rate of 47.8% when treated with ZERBAXA plus metronidazole vs 69.2% at the time treated with meropenem. A similar trend was also seen in the cUTI misery. Monitor CrCl at least daily in patients with changing renal function and adjust the disagreeable lot of ZERBAXA accordingly.
Hypersensitivity: ZERBAXA is contraindicated in patients through known serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, or other members of the beta-lactam rank. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions be delivered of been reported in patients receiving beta-lactam antibacterials. Before initiating therapy through ZERBAXA, make careful inquiry about former hypersensitivity reactions to cephalosporins, penicillins, or other beta-lactams. If some anaphylactic reaction to ZERBAXA occurs, cease use and institute appropriate therapy.
Clostridium difficile–associated diarrhea (CDAD), ranging from calm diarrhea to fatal colitis, has been reported through nearly all systemic antibacterial agents, including ZERBAXA. Careful therapeutic history is necessary because CDAD has been reported to occur again than two months after the administration of antibacterial agents. If CDAD is confirmed, antibacterial use not directed against C. difficile should have ~ing discontinued, if possible.
Development of unsalable article-resistant bacteria: Prescribing ZERBAXA in the non-appearance of a proven or strongly suspected bacterial contagion is unlikely to provide benefit to the indefatigable and increases the risk of the development of drug-resistant bacteria.
Adverse reactions: The greatest in number common adverse reactions occurring in ≥5% of patients were headache (5.8%) in the cUTI suit, and nausea (7.9%), diarrhea (6.2%) and pyrexia (5.6%) in the cIAI affliction.
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Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA
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The group undertakes no obligation to publicly update any forward-looking statement, whether as a eventuate of new information, future events or other causes. Additional factors that could cause results to wrangle materially from those described in the despatch-looking statements can be found in the company’s 2014 Annual Report in c~tinuance Form 10-K and the company’s other filings by the Securities and Exchange Commission (SEC) available at the SEC’s Internet seat (www.sec.gov).
Please see Prescribing Information during ZERBAXA (ceftolozane and tazobactam) athttp://zerbaxa.com/pdf/PrescribingInformation.pdf.
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