The US Food and Drug Administration (FDA) has approved Janssen Pharmaceuticals' Invokana (canagliflozin) for the treatment of adults with type 2 diabetes. Invokana is the first in a new class of medications called s odium glucose co-transporter 2 (SGLT2) inhibitors to be approved in the United States . It is also the only oral, once - daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trials .
“Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life - threatening complications,” said Richard Aguilar, medical director, Diabetes Nation , LLC and Diabetes Care Foundation , a non - profit organization committed to improving diabetes care. " Invokana is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a ‘glucuretic,’ increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes–glucose in the urine –may also reflect the efficacy of a new and unique approach to treatment.”
The kidneys make an important contribution to balancing blood glucose. As glucose is filtered from the blood into the kidneys, it is reabsorbed back into the bloodstream. An important carrier responsible for this reabsorption is called sodium glucose co - transporter 2 (SGLT2). Invokana selectively inhibits SGLT2, and as a result promotes the loss of glucose in the urine, lowering blood glucose levels in adults with type 2 diabetes.
“Invokana provides patients with type 2 diabetes the option of a once-daily oral therapy that offers improved glycemic control and , in phase 3 studies , showed a n incidence of hypoglycaemia – low blood glucose – that was lower than with glimepiride and similar to that of sitagliptin,” said Jimmy Ren, Therapeutic Area Lead, Metabolics, Medical Affairs, Janssen Pharmaceuticals , Inc. “In addition, this new treatment option is associated wit h reductions in body weight and systolic blood pressure.”
Invokana is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes . Invokana has been studied as a single agent (monotherapy) , in combination with metformin, and in combination with other glucose - lowering agents, including insulin , in patients who need further glucose control. Results from the phase 3 studies showed Invokana was generally well tolerated. The most common adverse events with Invokana are genital mycotic (fungal) infections , urinary tract infections and increased urination . These specific adverse events were generally mild to moderate in intensity and infrequently led to discontinuation in phase 3 studies. Overall the rate of discontinuation due to adverse events was 4.3 per cent for the Invokana starting dose of 100 milligrams (mg), 3.6 per cent for Invokana 300 mg and 3.1 per cent versus competitors.
Invokana is an important addition to the comprehensive platform of offerings for patients with diabetes from the Johnson & Johnson Family of Companies. Janssen will partner with other Johnson & Johnson companies focused on diabetes, such as LifeScan, Inc., and Animas Corporation, to bring Invokana to healthcare professionals treating patients with diabetes.
Janssen also will offer a dedicated Invokana CarePath support programme to patients and caregivers. The program provides important support and information regarding affordable access, adherence and education, thereby helping patients to start and appropriately manage their disease and therapy over time.
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,” said Kirk Ways, Development Head, Cardiovascular & Metabolism and Compound Development Team Leader, Canagliflozin, Janssen Research & Development.
The new drug application for Invokana was based on a comprehensive global phase 3 clinical programme, which enrolled 10,285 patients in nine studies and is one of the largest clinical programs in type 2 diabetes submitted to health authorities to date.
As a member of the Janssen Pharmaceutical Companies of Johnson & Johnson, Janssen Pharmaceuticals, Inc. is dedicated to addressing and resolving the major unmet medical needs of our time. Driven by our commitment to patients, healthcare professionals, and caregivers, we strive to develop sustainable and integrated healthcare solutions b y working in partnership with all stakeholders on the basis of trust and transparency.