Johnson & Johnson’s subsidiary Janssen Pharmaceuticals announced promising efficacy results from a Phase II study showing improvements in blood sugar levels in type 1 diabetics who were treated with its type 2 diabetes drug Invokana. But the news was dampened when the Food and Drug Administration (FDA) issued new warnings for Invokana the same week as the pharmaceutical company’s announcement.
Invokana, known chemically as canagliflozin, is in a class of diabetes drugs known as SGLT2 inhibitors. The medication is approved to treat patients with type 2 diabetes, but Janssen’s latest study focused on patients with type 1 diabetes, formerly known as juvenile diabetes.
The 18-week randomized trial reviewed daily mean glucose, glycemic variability and time spent in target glycemic ranges in 351 adults with inadequately controlled type 1 diabetes. Participants were given either 100mg doses of Invokana, 300mg doses of Invokana, or a placebo as an add-on to insulin. The data showed that patents treated with 100mg and 300mg of Invokana had 11.6 percent and 10.1 percent increase in time spent within target glucose range.
Just as the data was being rolled out at the 76th Annual Scientific Sessions of the American Diabetes Association in New Orleans, the FDA strengthened warnings on Invokana as well as to other SGLT2 inhibitors – Farxiga and Xigduo – over acute kidney injury. The warning comes just months after the FDA warned that Invokana and other SGLT2 inhibitors could increase the risk of serous urinary tract infections and ketoacidosis, a serious condition in which too much acid builds up in the blood. The risk of ketoacidosis was also seen in trials of type 1 diabetics treated with Invokana.
The drugs have also been linked to decreases in bone mineral density and bone fractures. And, the FDA is currently investigating an increased risk of lower limb amputations in patients taking Invokana.
Source: The Pharma Letter