Regulatory Decision Summary for Zerbaxa

Review decision

The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.


Product type:

Drug

Medicinal ingredient(s):

ceftolozane and tazobactam

Therapeutic area:

cephalosporin / β-lactamase inhibitor

Type of submission:

Priority Supplement to a New Drug Submission

Control number:

224729
What was the purpose of this submission?

 

This Priority Supplemental New Drug Submission (SNDS) was filed to obtain market authorization for a new indication for Zerbaxa along with an increased dosage for this indication. Currently, Zerbaxa (ceftolozane and tazobactam) is indicated for the treatment of patients 18 years of age or older with complicated intra-abdominal infections (cIAI), and complicated urinary tract infection (cUTI), including pyelonephritis, when caused by susceptible strains of microorganisms. The currently approved dose of 1.5 g Zerbaxa is administered by intravenous infusion (IV) over 1 hour, every 8 hours. The new indication proposed is for the treatment of nosocomial pneumonia (hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP)), caused by susceptible Gram-negative microorganisms and the proposed dose is 3 g (i.e. double that of the currently approved dose). Due to the proposed new indication, changes were proposed to Part III of the Product Monograph (PM) and the currently approved Package Insert. A labelling review for this SNDS was, therefore, required.

 

Why was the decision issued?

 

Zerbaxa (ceftolozane / tazobactam) has been shown efficacious and noninferior to the comparator drug, meropenem, in the Phase III pivotal clinical trial for the treatment of nosocomial pneumonia in subjects 18 years or older when administered at a dose of 3 g q8h by intravenous infusion (IV) over 1 hour for 8 to 14 days. In the ventilated HABP sub-group, a favorable response for Zerbaxa in 28-day all-cause mortality was observed. In the VABP subgroup, 28-day all-cause mortality was 24.0% (63/263) for Zerbaxa and 20.3% (52/256) for meropenem, for a weighted proportion difference of -3.6 (stratified 95% confidence interval [CI]: -10.74, 3.52). The Product Monograph adequately reflects this information.

Based on the clinical review of the safety and efficacy data provided in support of this Supplemental New Drug Submission (SNDS), the revised Zerbaxa (ceftolozane / tazobactam) Product Monograph (PM) (dated August 12, 2019) is considered acceptable at this time. Residual safety risks will be mitigated by the Marketed Health Products Directorate (MHPD) through review of post-market information. Health Canada considers that the benefit-risk profile for intravenous Zerbaxa (ceftolozane / tazobactam) to be favourable, when used as labelled in the approved populations and indications.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.