Regulatory Decision Summary for Ivozfo
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.
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What was the purpose of this submission?
The purpose of this New Drug Submission was to seek market authorization for Ivozfo (fosfomycin for injection) for the treatment of the following infections in adults and children (including neonates): osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis, and bacteremia that occurs in association with any of these infections.
As per the sponsor, Ivozfo should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of the infections listed, or when these alternative antibacterial agents have failed to demonstrate efficacy.
This submission was in the form of a submission relying on third party data because original clinical studies supporting drug authorization are outdated; the current supporting data were predominantly from the published literature and from European market experience.
Why was the decision issued?
Health Canada considers that the benefit/risk profile for intravenous fosfomycin is favorable when used as labelled in the approved populations (adults and children, including neonates) and indications: osteomyelitis, nosocomial lower respiratory tract infections, complicated urinary tract infections, bacterial meningitis, and bacteremia associated with any of these infections. The efficacy and safety data supporting these indications are derived from the literature, including current clinical practice guidelines, systematic reviews and meta-analysis, ongoing European pharmacovigilance reporting, and the European Summary of Product Characteristics. Fosfomycin should be considered a second line therapy as per the label and the World Heath Organization (WHO) recommendation that it be on the Reserve List of essential medicines.
The clinical indications and the dosing recommendations for Ivozfo correspond to those of the European Reference Medicinal Product, Fomicyt. Intravenous fosfomycin is an established drug with a European market history of close to forty years.
Antimicrobial resistance is a concern both in Canada and globally, and there is an urgent and ongoing need for access to antimicrobials with novel mechanisms of action. Beta-lactam antibacterials in particular are threatened by spreading resistance via extended-spectrum-beta-lactamases or carbapenemases. In an era of antibiotic resistance and limited new treatment options, intravenous fosfomycin could be a useful addition to the antibacterial armamentarium in Canada.
There are various options available in Canada for the treatment of the infections requested for intravenous fosfomycin. The alternatives to fosfomycin include other broad-spectrum antibiotics, particularly carbapenems, cephalosporins and aminoglycosides. However, with increasing resistance to antibacterials, in particular amongst certain gram-negative bacteria, there is a need for alternate treatment options. Drug resistant infections in hospitalized and critically ill patients are associated with high morbidity and mortality.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| IVOZFO | 02488086 | VERITY PHARMACEUTICALS INC. | FOSFOMYCIN (FOSFOMYCIN SODIUM) 4 G / VIAL |
| IVOZFO | 02488094 | VERITY PHARMACEUTICALS INC. | FOSFOMYCIN (FOSFOMYCIN SODIUM) 8 G / VIAL |
| IVOZFO | 02488078 | VERITY PHARMACEUTICALS INC. | FOSFOMYCIN (FOSFOMYCIN SODIUM) 2 G / VIAL |