Johnson & Johnson’s Janssen Pharmaceuticals is awaiting FDA approval of an extended release version of its type 2 diabetes drug Invokamet, a combination of its Invokana and the long-used first-line diabetes treatment metformin.
Patients prescribed Invokamet XR will take two tablets daily as an adjunctive treatment to diet and exercise for improved glycemic control for the treatment of type 2 diabetes.
Invokana, which is known chemically as canagliflozin, was approved by the FDA in 2013, and was the first in a new class of diabetes treatments known as SGLT2 inhibitors. Invokamet was approved in 2014. Invokamet XR will be the first fixed-dose combination tablet containing canagliflozin and immediate-release metformin.
During its review of Invokamet XR, the FDA will review clinical trials where the safety of the drug was tested on patients. Side effects for Invokamet XR are similar to those of Invokana and Invokamet and include dehydration. The medication will also come with a warning for ketoacidosis.
Ketoacidosis is a serious condition in which the body produces too much acid in the blood. It can cause symptoms such as difficulty breathing, nausea, vomiting, abdominal pain, confusion and unusual fatigue or sleepiness. Without medical intervention, ketoacidosis can lead to diabetic coma and death.
Ketoacidosis is generally identified in patients with high blood sugar levels and a high number of ketones in their urine. However, patients taking Invokana and other SGLT2 inhibitors have been diagnosed with the condition without elevated blood sugar levels.
The FDA has not given any word when it will make a decision on whether to allow Invokamet XR to be marketed in the United States.
Source: Pharmacy Times