FDA Approves New Drug to Treat Diabetes

Janssen Pharmaceuticals has received a nod from the U.S. Food and Drug Administration for its new drug Invokana (canaglilozin) which is used for the treatment of type 2 diabetes.

The drug should be used along with a healthy diet and adequate exercise in order to improve the glycemic control in adults who are victims of type 2 diabetes. Type 2 diabetes is one of the most common forms of diabetes that affects nearly 24 million people, and accounts for 90 percent of the diabetes cases that are diagnosed in the U.S. Over a period of time, high blood sugar levels increases the risk of several health complications such as heart disease, blindness and nerve and kidney damage.

"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research said in a press statement. "We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health."

Invokana increases the glucose excretion and lowers blood glucose levels in victims of diabetes with elevated blood glucose levels by blocking the reabsorption of glucose.

The drug was approved by the FDA after nine clinical trials that were conducted on 10,285 patients who are victims of type 2 diabetes.

In the trials conducted, the researchers noticed an improvement in hemoglobin A1C levels, as well as in fasting plasma glucose levels.

Invokana is not recommended to treat people suffering with type 1 diabetes. Also, those who have high ketones in their blood or urine, and those who are suffering with severe renal impairment or are on dialysis should not be administered this drug.

The side effects included vaginal yeast infection and urinary tract infection. Apart from this, it caused intravascular volume, leading to othostatic or postural hypotension, resulting in dizziness and fainting.

FDA requires Janssen to conduct five post-marketing studies for Invokana that includes cardiovascular outcomes trial, enhanced pharmacovigilance program in order to check for malignancies, abnormalities in liver, adverse pregnancy results, bone safety study and photosensitivity reactions.

Apart from this, the company has to conduct two pediatric studies under Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study, and a safety and efficacy study.