Regulatory Decision Summary for Glyxambi
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?
This Supplemental New Drug Submission (SNDS) was submitted to add a new indication for Glyxambi (empagliflozin and linagliptin) for use in combination with metformin as an adjunct to diet and exercise, in adult patients with type 2 diabetes mellitus (T2DM) who are already controlled with the free combination of metformin, empagliflozin and linagliptin.
Why was the decision issued?
In the current SNDS, the applicant has provided a new study (1275.21) comparing the bioavailability of empagliflozin and linagliptin from the proposed fixed dose combination Glyxambi tablet (10 mg / 5 mg) with the co-administered individual components (10 mg empagliflozin tablets and 5 mg linagliptin tablets). The results demonstrated that the Glyxambi tablet met the standards for equivalent bioavailability in comparison to co-administration of the individual tablets.
The benefit-harm-uncertainty assessment for the proposed indication for Glyxambi; in patients with type 2 diabetes mellitus (T2DM) who are already controlled with the free combination of metformin, empagliflozin and linagliptin, is favourable. A Notice Of Compliance (NOC) is recommended. The revised Product Monograph dated December 5, 2017 is approved.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.