First "artificial pancreas" for diabetes approved, plus 2 more FDA actions

September 29, 2016

FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases. Here are the top 3 new approvals.

FDA recently approved several medications and devices across several therapy areas: diabetes, weight loss and rare, auto-inflammatory diseases.

Here are the top 3 new approvals:

1. The first device to automatically monitor blood sugar and provide appropriate basal insulin doses for patients with type 1 diabetes has been approved. Medtronic’s MiniMed 670G hybrid closed looped system, often referred to as an “artificial pancreas,” is intended to adjust insulin levels with little or no input from the user. It works by measuring glucose levels every 5 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.

Related: FDA approves long-acting insulin drugs

“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,” Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health, said in a statement.

FDA evaluated data from a clinical trial of the devices that included 123 participants with type 1 diabetes. The trial showed that the MiniMed device is safe for use in people aged 14 years and older with type 1 diabetes. No serious adverse events, diabetic ketoacidosis (DKA) or severe hypoglycemia were reported during the study. As part of this approval, FDA is requiring a post-market study to better understand how the device performs in real-world settings.

2. FDA approved phentermine hydrochloride USP (Lomaira, KVK Tech) 8 mg tablets CIV, a low-dose medicine for weight reduction in adults with an initial body mass index (BMI) of 30 or more (obese) or 27 or more (overweight) with at least 1 weight-related condition such as controlled high blood pressure, diabetes or high cholesterol. Lomaira, which is only recommended for a short period of time, should be used together with regular exercise and a reduced-calorie diet.

“Lomaira is the only strength of phentermine hydrochloride that can be taken up to three times a day before meals,” according to a KVK Tech statement. At 50 cents per tablet, Lomaira is an affordable new option for treating the obesity epidemic in America, which has spread to nearly 35% of American adults, the company said. “Lomaira is reasonably priced to ensure that cost does not create a hurdle, despite the fact that two-thirds of Americans pay out-of-pocket for their weight-loss prescription medications,” the statement said.

Related: Invokamet extended-release approved for diabetes

Next: Auto-inflammatory diseases

 

 

3.  FDA recently approved 3 new indications for canakinumab (Ilaris, Novartis). The new indications are for rare and serious auto-inflammatory diseases in adult and pediatric patients: tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD) and familial Mediterranean fever (FMF).

All 3 syndromes are hereditary diseases characterized by periodic attacks of fever and inflammation, as well as severe muscle pain. There are no previously-approved therapies for TRAPS or HIDS/MKD, according to a FDA statement.

“For the first time, patients with TRAPS and HIDS/MKD, two painful and life-altering diseases, have access to a treatment that may help improve their quality of life,” Badrul Chowdhury, MD, director of the Division of Pulmonary, Allergy and Rheumatology Products in FDA’s Center for Drug Evaluation and Research, said in the statement.

Approvals for the new indications were based on clinical studies, including safety, efficacy and pharmacokinetic data. The most common adverse reactions for these indications are injection site reactions and being more susceptible to catching colds. Ilaris can also cause serious side effects, including increased risk of serious infections and the decreased ability to fight infections (immunosuppression) and allergic reactions.

Read more: FDA approves rare liver disease drug