Health Canada grants Intravenous Fosfomycin priority review status.
Toronto, Ontario (July 16, 2018) – Following a pre-NDS meeting and subsequent application to fast‑track the review process, Intravenous Fosfomycin has been granted priority review status by Health Canada.
Under priority review status the NDS (new drug submission) is deemed to meet an unmet medical need in Canada. Moreover, the NDS will be reviewed by Health Canada within 180 days of submission, as opposed to the normal review period of 300 days.
Intravenous Fosfomycin (Fosfomycin I.V.), first in a new class of epoxide-based antibiotics, has a broad spectrum of bactericidal Gram-negative and Gram-positive activity, including activity against most contemporary MDR (multi‑drug resistant) strains found in hospitalized patients across Canada.
It has a proven track record in Europe, the UK, and Japan, with indications for osteomyelitis, complicated urinary tract infections, hospital‑acquired lower respiratory tract infections, bacterial meningitis and sepsis. Delivering both safety and efficacy for more than 40 years, its unique structure and novel mechanism of action distinguishes it from all other marketed classes of antimicrobial agents and has allowed for its continued use with little or no bacterial resistance.
“Priority review is an important step closer to providing the Canadian healthcare community with a new option for patients with hard‑to‑treat infections. While there is still much work to do in the months ahead, we feel that the path forward is clear and look towards a Health Canada review and comments in 2018, and ultimately a NDS approval in early 2019.
In the meantime, we have been able to facilitate a supply line through Health Canada’s Special Access Program for physicians who are currently seeking Fosfomycin I.V. for their patients.” – Howard Glase, CEO Verity Pharma
“Whether in Canada or worldwide, hospitals are facing the growing presence of infections caused by antimicrobial-resistant, multidrug-resistant (MDR), and extensively-drug-resistant (XDR) pathogens. The urgent need for new antimicrobials in Canada has been underscored in a recently published paper which suggests that Intravenous Fosfomycin will be a valued agent for Infectious Disease experts to consider.” – Dr. Neil Fleshner MD, MPH, FRCSC, Chief Medical Officer, Verity Scientific Advisory Board.
For further review, the entire paper, ‘Intravenous Fosfomycin: An Assessment of Its Potential for Use in the Treatment of Systemic Infections in Canada’ can be accessed at this link: https://www.hindawi.com/journals/cjidmm/2018/8912039/
About Verity Pharma
Verity Pharma is a specialty pharmaceutical company focused on providing therapeutically relevant legacy agents to the Canadian healthcare community. Our mission is to provide access to prescription products that are in short supply or have not yet been made available in Canada. Fosfomycin I.V. is just one of a number of important Verity product launches lined up for 2019.