- Abbott has received 510(k) clearance from the Food and Drug Administration for FreeStyle Libre 3, the latest version of its continuous glucose monitor.
- The 14-day device is smaller and thinner than its predecessor, at about the size of two U.S. pennies stacked, and sends readings to a connected smartphone every minute. Abbott claims Libre 3 is the most accurate 14-day CGM, based on results published in an abstract from the American Diabetes Association's 82nd Scientific Sessions.
- Securing the clearance gives Abbott a head start on Dexcom’s rival next-generation CGM — the G7 system — which is expected to receive clearance from the FDA in June or later. Abbott is focusing on accuracy, size and affordability as it makes its case for Libre 3 over devices from competitors.
Abbott received a CE mark for Libre 3 in September 2020 and has since provided optimistic updates on the early stages of the device's commercialization. In April, Abbott CEO Robert Ford told investors that, after a limited rollout in Germany, the company had the confidence to accelerate the transition to Libre 3. Ford expects the transition to be faster than the move from Libre 1 to 2, which took about a year.
Boosting international sales is key to the Libre line of products. In the first quarter, markets outside of the U.S. accounted for 70% of diabetes revenue. Libre accounts for almost 90% of the diabetes business. Still, the U.S. remains the growth driver for Abbott, with diabetes-device sales rising 36% in the quarter compared with 8% growth internationally.
The 510(k) clearance gives Abbott an opportunity to maintain its momentum in the U.S. Abbott is selling Libre 3 at the same price as its predecessor. The company also has called out the device's minute-by-minute glucose readings, its compact size and its 33-foot Bluetooth range.
Abbott’s focus on affordability comes as it tries to convert more users to Libre. While global Libre sales reached $1 billion in the first quarter, the device is used by a fraction of people with diabetes. Abbott says its Libre CGMs are used by “approximately four million people across more than 60 countries.”
Analysts at RBC Capital Markets see the potential for Abbott to add tens of millions of users, including people with Type 2 diabetes, over time. Writing in a note to investors about the FDA clearance, the analysts set out the implications of the 510(k) decision for Abbott’s growth.
“The news is a positive one as Libre is an important growth driver for [Abbott] and the clearance allows the company to bring its latest generation diabetes technology to market,” the analysts wrote. “Libre 3 has seen strong traction overseas, and we expect strong uptake in the U.S. as well.”
The analysts expect Libre sales to grow to $4.5 billion this year and rise to almost $8 billion by 2025.
Rival Dexcom had reportedly considered adding insulin pumps to its existing CGM franchise with an acquisition of Insulet, but denied plans to buy the company in a Tuesday announcement.