The US food and drug administration (FDA) has approved Janssen's Invokana (canagliflozin) for the treatment of adults with type 2 diabetes.
Invokana is the oral, once-daily medication available in the US demonstrating improved glycemic control and reduced body weight and systolic blood pressure in clinical trials.
Janssen Pharmaceuticals medical affairs metabolics therapeutic area lead Jimmy Ren said that Invokana provides the patients with the option of a once-daily oral therapy that offers improved glycemic control and, in Phase 3 studies, showed an incidence of hypoglycemia, low blood glucose, which is lower than glimepiride and similar to sitagliptin.
"In addition, this new treatment option is associated with reductions in body weight and systolic blood pressure," Ren added.
Results from the Phase 3 studies showed Invokana was generally well tolerated and the most common adverse events with Invokana are genital mycotic (fungal) infections, urinary tract infections and increased urination.
Janssen Research & Development canagliflozin, cardiovascular and metabolism and compound, development team leader Kirk Ways said, "We are delighted with the approval of INVOKANA because it provides a much-needed, new treatment option to help adults with type 2 diabetes and their physicians manage this disease."
Janssen will partner with other Johnson & Johnson companies focused on diabetes, such as LifeScan and Animas Corporation, to bring Invokana to healthcare professionals treating patients with diabetes.
Janssen and its affiliates have marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand, and parts of Asia through a license agreement with Mitsubishi Tanabe Pharma.
