Janssen receives FDA approval for CV events drug for adults

Janssen Pharmaceutical has received approval from the FDA for the use of Canagliflozin to minimise the risk of major adverse cardiovascular (CV) events in adults.

The indication covers CV events such as heart attack, stroke or death in patients with type 2 diabetes (T2D) and have a known CV condition.

Canagliflozin is an oral, prescription medicine to decrease glucose levels in adults with T2D. The drug must be used along with diet and exercise.

Janssen said that the FDA decision comes after the American Diabetes Association and the American Association of Clinical Endocrinologists released reports supporting Canagliflozin use.

Janssen Research & Development cardiovascular and metabolism global therapeutic area head James List said: “This FDA approval makes Canagliflozin the only oral type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death.

“Not only does Canagliflozin enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events.”

Canagliflozin’s effect on CV risk was assessed in the CANVAS Program that involved a total of more than 10,000 adults with T2D and established CV disease or at risk for the disease with two or more risk factors.

The overall data showed that the drug in combination with standard of care led to a 14% decrease in the combined risk of heart attack, stroke and CV death, compared to placebo.

For participants with established CV disease, Canagliflozin reduced the combined risk of heart attack, stroke and CV death by 18%.

Source: Pharmaceutical Technology