The European Commission (EC) has approved expanded labelling of Janssen Pharmaceutical’s Invokana and Vokanamet to include positive cardiovascular outcomes.
Invokana (canagliflozin) obtained the European regulatory approval in 2013 as an adjunct treatment for adults with insufficiently controlled type 2 diabetes mellitus, to diet and exercise.
The drug is an oral, once-daily sodium glucose co-transporter 2 (SGLT2) inhibitor. Vokanamet is a fixed-dose combination of canagliflozin and metformin, and approved for the same indication.
The latest update to the labelling of Invokana and Vokanamet is based on findings from the CANVAS Program conducted in a total of 10,000 patients.
The study showed a decrease in major adverse cardiovascular (CV) events in type 2 diabetes patients who had a history of CV disease or at least two CV risk factors.
Data showed that the trial met its primary endpoint, where canagliflozin significantly reduced the combined risk of CV death, myocardial infarction and non-fatal stroke compared with placebo.
Previous labelling of Invokana and Vokanamet covers results on improving glycemic control.
Janssen-Cilag Farmacêutica EMEA Medical Affairs vice-president Jose Antonio Buron said: “We hope this approval will not only provide clinicians with a more detailed overview of canagliflozin but also help them when making informed treatment decisions which are most appropriate for their patients.
“Type 2 diabetes mellitus is one of the most common forms of diabetes and accounts for the majority of diabetes cases worldwide so it is extremely important that we continue improving outcomes for these patients.”
In the CANVAS Program, canagliflozin was found to significantly decrease the risk of hospitalisation for heart failure and improve renal outcomes.
The drug, however, demonstrated a nearly two-fold increase in risk of lower limb amputation in patients who had established CV disease or at least two risk factors for the disease.