Abbott’s wins approval for Freestyle Libre 14-day Flash glucose in US

Abbott’s wins approval for Freestyle Libre 14-day Flash glucose in US

July 31, 2018 1 By engineeringplm

Abbott announced that the US Food and Drug Administration (FDA) has approved the FreeStyle Libre 14 Day Flash Glucose Monitoring System, making it the longest-lasting self-applied personal glucose sensor available for patients with diabetes.

The system is now the longest continuous glucose monitor available in the U.S., Abbott said. Earlier it was 10-day version which was approved by FDA in September.

“At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes,” Jared Watkin, the company’s senior vice president of Diabetes Care, said in the press release. “With the new FreeStyle Libre 14-day system, people with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition.”

The Freestyle Libre system is supported by both clinical data and real-world evidence that show that people who scan more frequently spend less time in hypoglycemia (low-glucose levels) or hyperglycemia (high-glucose levels) while having improved average glucose levels, demonstrating improved glucose control overall. Abbott said the FreeStyle Libre 14 day system will be available via prescription in the coming months at participating pharmacies and durable medical equipment suppliers in the U.S.

The sensor is about the size of two stacked quarters and can be self-applied to the back of the upper arm to provide real-time glucose updates. It eliminates the need for routine finger sticks.

“Instead of three sensors every month its two sensors every month that people need to wear,” Chris Thomas, director of biosensor technology for Abbott, told MD+DI. “Our whole goal is to continuously improve Freestyle Libre so that it seamlessly blends into your life and it makes life easier for people with diabetes.”

Thomas also said there was no doubt the Freestyle Libre was a game changer for Abbott and said the sensor could lead to strong growth for the company.”We expect sales in the $90 million to $100 million range driven by the U.S. for 2018,” Thomas said. “Freestyle Libre is about 50% of our diabetes sales in 2018.”