dm+d

31009911000001106

Refrigerated Storage

Zerbaxa Merck Sharp & Dohme Limited

Merck Sharp & Dohme Limited
Zerbaxa
Concentrate for solution for infusion, 1g/0.5g

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15 May 2020
London MI Service

New Medicines

ZerbaxaHospital-associated pneumonia

Information

Zerbaxa
Licence extension / variation
Merck Sharp & Dohme (MSD)
Merck & Co (name used in US for MSD)

Development and Regulatory status

Launched
Launched
Launched
August 2019
Aug 19Licence change for treatment of adults with hospital-acquired pneumonia, including ventilator-associated pneumonia approved in EU [15].
Jul 19Recommended for EU approval by CHMP with the broader indication of hospital acquired pneumonia generally - the additional indication is "Hospital-acquired pneumonia (HAP), including ventilator‑associated pneumonia (VAP)." [13].
Jun 19Approved in US [12].
Apr 19Filed in EU and US. US FDA has set a PDUFA date of 3/6/19. Submission includes late-stage data from PIII ASPECT-NP trial. Study (n=726) showed Zerbaxa was non-inferior to meropenem after 28 days in ITT population [11].
Feb 19Granted priority review in US [10].
Sep 18Following results from ASPECT-NP trial, Merck announce plans to seek approval from FDA and EMA for Zerbaxa in ventilated HABP or ventilator-associated bacterial pneumonia (VABP) [9].
Mar 18PIII development continues [7].
Oct 15PIII development continues [4].
May 13The FDA has granted fast track status for ceftolozane/tazobactam in hospital-acquired bacterial pneumonia, ventilator-associated bacterial pneumonia and complicated urinary tract infections [2].
Mar 13PIII study to start mid-2013 [1].

Category

Combination of a novel cephalosporin (CXA-101) with the beta-lactamase inhibitor tazobactam
Hospital-acquired pneumonia (HAP) affects 0.5-1% of inpatients and is the most common healthcare-associated infection contributing to death. In some patients, HAP is associated with mechanical ventilation; ventilator-associated pneumonia (VAP) has a 24% to 50% mortality rate, increasing to 76% if infection is caused by multidrug-resistant pathogens. VAP accounts for up to 25% of all ICU infections. (J. Antimicrob. Chemother. (2008) 62 (1): 5-34.)
Hospital-associated pneumonia
Intravenous

Trial or other data

Sep 19PIII RCT (NCT02070757; n=726) found high-dose ceftolozane–tazobactam was non-inferior to meropenem in terms of both 28-day all-cause mortality (24.0 vs. 25.3% died, respectively) and clinical cure at test of cure (54% vs 53%, respectively) for gram-negative nosocomial pneumonia in this population [14].
Jan 19PII VECTOR study (NCT01853982) was electively terminated to focus on larger registrational study [9].
Sep 18PIII ASPECT-NP study (n=726) meets pre-specified endpoints demonstrating non-inferiority of Zerbaxa to meropenem in day 28 all-cause mortality and clinical cure rate at test-of-cure visit [8].
Mar 18NCT02070757 still recruiting pts. The estimated study completion date is now 2018 [7].
Dec 16NCT02070757 currently recruiting patients. Collection of primary outcome should now complete September 2018 [6].
Jan 16NCT01853982 was terminated in Jul 15 to focus on the larger PIII study; NCT02070757 is ongoing in the US and Europe and still recruiting patients. It is expected to complete Feb 18 [5].
Feb 14NCT02070757 (ASPECT-NP) is a randomized, double-blind, multicentre, PIII study of IV ceftolozane/tazobactam vs meropenem in 726 adult patients with ventilated nosocomial pneumonia. The primary outcome is all-cause mortaility at day 28. The study starts Jun 14 and is due to complete Feb 18 [4].
May 13NCT01853982: CXA-NP-11-08:(VECTOR) is a multicentre, open-label, randomized study of IV ceftolozane/tazobactam (8 hourly) with that of piperacillin/tazobactam (6 hourly) in 300 patients with ventilator associated pneumonia. The primary outcome is clinical response 24 hours after last dose of study drug in the mITT population. The study starts May 13 and is due to complete Jan 16 [3].
Feb 13The FDA granted Qualified Infectious Disease Product (QIDP) designation for ceftolozane/tazobactam for the treatment of hospital-acquired bacterial pneumonia (HABP)/Ventilator-associated bacterial pneumonia (VABP) [1].

Evidence based evaluations