Summary of Cancellation for MV140 mucosal bacterial vaccine; Inactivated Escherichia coli / Klebsiella pneumoniae / Enterococcus faecalis / Proteus vulgaris (*Urofyn)
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:
Contact:
Contact:
Office of Regulatory Affairs, Biologic and Radiopharmaceutical Drugs Directorate
Medicinal ingredient(s):
MV140 mucosal bacterial vaccine; Inactivated Escherichia coli / Klebsiella pneumoniae / Enterococcus faecalis / Proteus vulgaris
Therapeutic area:
Type of submission:
New Drug Submission (New Active Substance)
Control number:
Decision issued:
No decision was issued by Health Canada. The company has cancelled the submission before a final decision was issued.
Date of cancellation:
2023-05-26
What was the purpose of this submission?
The purpose of this submission is to seek marketing authorization for Urofyn (MV140 mucosal bacterial vaccine; inactivated Escherichia coli / Klebsiella pneumoniae / Enterococcus faecalis / Proteus vulgaris) indicated for the prevention of recurrent urinary tract bacterial infections (rUTIs).
What did the company submit to supports its submission?
The sponsor submitted drug quality, non-clinical and clinical components. Study MV140-SLG-003 was provided as the pivotal study: A multicentre, prospective, randomized, double-blind, parallel-group placebo-controlled clinical study for the assessment of the immunomodulatory efficacy, safety and clinical impact after three and six months treatment with a sublingual polyvalent bacterial vaccine (in oral mucosa) in women with rUTIs.
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
Health Canada’s review of the submission was incomplete at the time of cancellation. During review, Health Canada identified that they were unable to entirely assess the chemistry and manufacturing of the product from the data that was available. Health Canada notified the sponsor of these issues, and the submission was subsequently voluntarily withdrawn.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
This product is not currently accessed via the SAP. There is no expected impact for patients in clinical trials.
*Proposed Brand Name:
Urofyn
Manufacturer:
Red Leaf Medical Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2022-03-25