MDDI Online is part of the Informa Markets Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

Are Investors Growing Impatient for FDA Approval of Abbott's Libre 2 iCGM?

An analyst question during Abbott's third-quarter earnings call suggests some investors may be growing concerned about the prolonged U.S. regulatory timeline for the second-generation of the popular continuous glucose monitor.

Abbott continues to wait for approval to launch its Libre 2 system in the United States. The second-generation of the blockbuster product is under FDA review as an interoperable continuous glucose monitoring system, meaning it will need to meet the special controls established by the agency.

Headshot courtesy of Abbott; graphic by Amanda Pedersen/MD+DI

Abbott Laboratories has been wildly successful with its FreeStyle Libre continuous glucose monitor (CGM) since winning FDA approval two years ago, but some investors may be getting restless as the U.S. market waits for the second-generation of the blockbuster technology.

Abbott won CE mark approval to launch the Libre 2 system in Europe in October 2018. The second-generation system offers optional customizable glucose alarms for patients who need them, using Bluetooth technology. The system can be set up to alert the user if their glucose is low or high, for example, or if there is a signal loss between the sensor and the reader. The user continues to be able to scan their sensor as often as desired to see their glucose reading, trends and patterns, and eight-hour history.

The company filed for FDA approval of Libre 2 as an interoperable continuous glucose monitoring (iCGM) system, meaning it will need to meet the special controls established by FDA when the agency authorized the Dexcom G6 iCGM in May 2018. Abbott's management team has previously assured investors that the company would not have submitted Libre 2 as an iCGM had it not clearly met the standards set by FDA. In fact, the company said it was encouraged by the agency to file Libre 2 as an iCGM.

But analysts and investors are beginning to get antsy, and Morgan Stanley's David Lewis mentioned during Abbott's third-quarter earnings call Wednesday that some investors are becoming concerned about the product, given the longer-than-expected wait time.

"Are you still confident in Libre 2 iCGM? And how are you thinking about the potential timing for that product?" Lewis asked Abbott CEO Miles White.

White said he is "absolutely" confident that Libre 2 will be approved by FDA.

"The product is performing wonderfully, the growth is strong, and the expansion is strong. There's a lot to be pretty encouraged about," he said. "And while I recognize a lot of people including us are feeling impatience, impatience doesn't translate to concern. We're all impatient, and you know we'd all like everything yesterday, but it's not quite working out as yesterday."

Abbott COO Robert Ford admitted that the review process is taking longer than expected, and he said the company is working through a handful of open items with the agency regarding the submission.

"I've got the same confidence level that Miles does. I'm confident in the data. I'm confident in the product," Ford said.

He pointed to the company's "exceptional" third-quarter Libre sales of just under $0.5 billion, putting Abbott on track for a growth rate of more than 70%.

"And in the U.S. sales nearly tripled," Ford said, attributing that growth to a "strong and steady" rate of new patients using Libre.

The company has been working to increase its manufacturing capacity to keep up with the demand for the product, and that plan is progressing on schedule, Ford said.

"So I think the momentum here on Libre is exceptional. It is very strong as we go into Q4. We've got a lot of stuff going right, firing on all cylinders, whether it's commercial, whether it's operation, whether it's our R&D program," Ford said. "So I'm very confident about the sustainability of Libre and Libre going forward."

Filed Under
500 characters remaining