The FDA approved an app for continuous glucose monitoring, a weight-loss device, a combination diabetes pill, and a new indication for an eye medication in the past month.
The Dexcom Share app allows people with diabetes to automatically and securely view data from their continuous glucose monitor (CGM) on their own phones and share it with another designated user's Apple mobile device, according to the FDA. The app receives real-time data directly from CGM and transmits it to a Web-based storage location, from which the app of the designated user can download it.
The weight-loss device, the Maestro Rechargeable System, targets the nerve pathway between the brain and the stomach. It is approved to treat patients age 18 and older who have not been able to lose weight with a weight-loss program and who have a body mass index of 35 to 45 kg/m2 with at least 1 other obesity-related condition, such as type 2 diabetes. It consists of a rechargeable electrical pulse generator, wire leads, and electrodes implanted surgically into the abdomen. In a trial, patients with the device lost 8.5% more weight in a year than controls. The clinical study did not meet its original end point, but the FDA concluded that the benefits outweighed risks of the device, according to a press release. Serious adverse events included nausea, pain at the device site, vomiting, and surgical complications. Other adverse events included pain, heartburn, problems swallowing, belching, mild nausea, and chest pain, an FDA release said.
Glyxambi, the newly approved pill, combines empagliflozin (10 or 25 mg) and linagliptin (5 mg) to improve glycemic control in adults with type 2 diabetes, according to a manufacturer press release. Efficacy was shown in trials comparing the combination pill plus metformin with each of the included drugs plus metformin. It does not treat type 1 diabetes or diabetic ketoacidosis and should not be taken by patients with severe renal impairment, end-stage renal disease, dialysis, or hypersensitivity reactions to linagliptin or empagliflozin. It has not been studied in patients with a history of pancreatitis, and there have been postmarketing reports of acute pancreatitis with linagliptin. The most common adverse reactions to the combination drug were urinary tract infection, nasopharyngitis, and upper respiratory tract infection.
An expanded approval for ranibizumab injection (Lucentis) allows it to be used for diabetic retinopathy (DR) in patients with diabetic macular edema (DME).The drug was previously approved to treat DME and macular edema secondary to retinal vein occlusions. The most common side effects include bleeding of the conjunctiva, eye pain, floaters, and increased intraocular pressure. Serious side effects include endophthalmitis and retinal detachments.