JNJ’s Animas Division Gets FDA Approval for Insulin Pump and CGM System

Chesterbrook, Pa.-based Animas Corp., a division of Johnson & Johnson received U.S. Food and Drug Administration approval for its Vibe insulin pump and continuous glucose monitoring (CGM) system for the management of insulin-requiring diabetes in adults ages 18 and older. Vibe allows patients to view glucose data and administer insulin right from the pump. According to the company, the device allows patients to simplify their “ability to make more informed decisions to fine tune insulin delivery and manage their diabetes.”

The system provides patients with their latest glucose readings on the pump screen and a complete view of glucose highs, lows and rates of change over time. This information complements fingerstick testing results and can be used to help guide immediate and long-term insulin delivery therapy adjustments. CGM technology measures glucose levels every five minutes and provides real-time glucose values, as well as trend information. CGM has been shown to improve glycemic control in adult patients 25 years and older via lower HbA1c levels, less frequent hypoglycemia, and reduced glucose variability, according to the company.

“For many people who are insulin dependent, diabetes is a demanding disease that can require day-to-day and hour-by-hour management. We are pleased to now offer people with diabetes in the U.S. a solution with CGM technology that provides the ability to make more informed decisions to manage their disease, which can ultimately improve blood glucose control,” said Brian Levy, M.D., chief medical officer for Animas.

Animas Vibe also offers precise insulin dosing with a low basal increment of 0.025 U/hr across all available ranges (0.025 U/hr to 25.00 U/hr) and a low bolus increment of 0.05 U across all available bolus ranges (0.05 U to 35.00 U). Users also can personalize dosing by choosing individual insulin-to-carb ratios, insulin sensitivity factors, and blood glucose targets in 30-minute increments with up to 12 personal settings.

Additional key features include:
• Dexcom CGM sensor technology is approved for up to seven days of continuous wear with one of the smallest introducer needles on the market. With Mean ARD (absolute relative difference) as the industry’s standard for measuring CGM accuracy, Dexcom’s 13% Mean ARD provides exceptional performance and accuracy for reliable results;
• Waterproof up to 12 feet for up to 24 hours; Dexcom G4 Platinum transmitter is water resistant up to 8 feet for 24 hours;
• CGM-enabled insulin pump with a high-contrast color screen, featuring color-coded graphs and arrows to indicate direction and rate of glucose change, revealing trends at a glance; and
• Customizable alarms to indicate high and low glucose levels.

“We are excited to bring Animas Vibe to the U.S., which expands our insulin delivery portfolio and delivers on our promise to provide a range of solutions that help patients perform at their very best,” said Ty Lee, vice president, Johnson & Johnson Diabetes Solutions.

Animas anticipates shipment to patients to begin in January 2015. The system already is available in Europe, Australia, New Zealand, and Canada.