Drug Topics — The FDA recently approved several new drugs – along with a novel device that can replace fingersticks and an “artificial pancreas” – for patients with diabetes. Here – in no particular order – is a brief overview of these innovative new products.
The G5 Mobile Continuous Glucose Monitoring System, made by Dexcom, can replace fingerstick blood glucose testing for diabetics. “This is the first FDA-approved continuous glucose monitoring system that can be used to make diabetes treatment decisions without confirmation with a traditional fingerstick test,” the FDA said in a statement.
Instead of fingersticks, the G5 Mobile Continuous Glucose Monitoring System uses a small sensor wire inserted just below the skin that continuously measures and monitors glucose levels. Real-time results are sent wirelessly every five minutes to a dedicated receiver and a compatible mobile device running a mobile app. Then, alarms and alerts indicate glucose levels above or below user-set thresholds.
The new combination drug, empagliflozin and metformin hydrochloride extended-release tablets (Synjardy XR), made by Boehringer Ingelheim and Eli Lilly, makes blood glucose control easier for patients with type 2 diabetes.
“Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition,” said Paul Fonteyne, President and CEO of Boehringer Ingelheim Pharmaceuticals. “With Synjardy XR…. adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment.
People with diabetes can now receive a single daily injectable combination drug via Xultophy 100/3.6, made by Novo Nordisk. Xultophy, a combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.
Novo Nordisk expects to launch Xultophy 100/3.6 in the US in the first half of 2017. The drug is administered as a once-daily injection from a prefilled pen, and can be taken with or without food.
Similar to Xultophy, FDA also recently approved Soliqua 100/33, made by Sanofi, a once-daily injection for type 2 diabetetes. Xultophy is a combination of Lantus (insulin glargine 100 units/mL) and lixisenatide, a GLP-1 receptor agonist. Soliqua 100/33 is available in retail pharmacies now.
Both Soliqua 100/33 and Xultophy 100/3.6 enter a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist (GLP-1 RA) in a single, once-daily injection.
The first “artificial pancreas,” a device to automatically monitor glucose and provide appropriate basal insulin doses for patients with type 1 diabetes, is a breakthrough in diabetes treatment. Medtronic’s MiniMed 670G hybrid closed-looped system is intended to adjust insulin levels with little or no input from the user. “This first-of-its-kind technology can provide people with type 1 diabetes greater freedom to live their lives without having to consistently and manually monitor baseline glucose levels and administer insulin,” said Jeffrey Shuren, MD, Director of FDA’s Center for Devices and Radiological Health, in a statement.
The novel device works by measuring glucose levels every five minutes and automatically administering or withholding insulin. The system includes a sensor that attaches to the body to measure glucose levels under the skin, an insulin pump strapped to the body, and an infusion patch connected to the pump with a catheter that delivers insulin.