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.