Johnson & Johnson subsidiary Janssen has announced Health Canada’s approval for Invokana (canagliflozin), indicated as an adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus.
Belonging to a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors, Invokana is an oral, once-daily prescription treatment used to lower blood glucose (sugar) levels in type 2 diabetes patients.
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Inhibiting SGLT2, Invokana lowers blood sugar levels by promoting the loss of glucose in the urine. Invokana may cause volume depletion (dehydration) due to its mechanism of action.
Health Canada has approved Invokana based on a comprehensive global Phase III clinical programme, including 713 Canadians in six studies.
In the Phase III clinical programme, Invokana was studied as a single agent (monotherapy), in combination with metformin and in combination with other glucose-lowering agents, including insulin, in patients who need further glucose control.
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The clinical programme outcome has demonstrated that the 100mg and the 300mg doses of canagliflozin significantly improved glycemic control, body weight and systolic blood pressure.
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By GlobalDataIn two studies comparing Invokana as an add-on therapy with metformin to current standard treatments, Invokana dosed at 300mg provided superior reductions compared to sitagliptin and to glimepiride in both A1C levels and body weight.
The Phase III clinical programme results demonstrated that Invokana was generally well-tolerated and the most common adverse events observed in the programme include genital mycotic (fungal) infections, urinary tract infections and increased urination.
LMC Diabetes and Endocrinology endocrinologist Dr Ronald Goldenberg said that in clinical trials, Invokana had a great impact on patients by improving glycemic control, while reducing body weight and systolic blood pressure.
"Invokana was also associated with a low incidence of hypoglycemia, which is something that is often associated with diabetes medications," Dr Goldenberg added. "This new treatment provides an exciting option for physicians and patients."
Image: Johnson & Johnson office in Madrid, Spain. Photo: courtesy of Zaqarbal.
