Abbott Patients Grow Impatient for Libre 2 Approval

Abbott Laboratories has been wildly successful with its FreeStyle Libre continuous glucose monitor (CGM) since winning FDA approval in 2017, but it seems some investors and patients may be getting restless as the U.S. market waits for the second-generation of the blockbuster technology.

We first noted some signs of impatience for Libre 2 in our coverage of Abbott's third-quarter earnings call in October. One reader commented on that article that "I don’t particularly care about investors becoming impatient, as a Freestyle Libre user I am growing impatient."

If a recent email to MD+DI is any indication, that patient is not alone.

"What can we consumers do to get this product approved for American use? The hold up by the FDA is ridiculous," John Grosse, an MD+DI reader, asked us in an email late last week.

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 said 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, the agency encouraged Abbott to file Libre 2 as an iCGM.

Abbott's management team was asked to revisit this restlessness Wednesay during the company's fourth-quarter earnings call.

"Last October I mentioned that we were working through a handful of issues," said Robert Ford, who is on deck to become CEO of Abbott at the end of March when Miles White retires. "Quite frankly, we encounter this handful of issues in other parts of our business too so it's nothing that is, for us, terribly surprising. It's normal."

White declined to reveal any specifics as to what those issues might be, but he did say he is pleased with the progress the company has made since October and that he is "very confident" in Libre 2 and its anticipated iCGM label.

Ford also noted that Abbott had a great fourth quarter with Libre even without having Libre 2 approved in the United States. "As Miles said, we're the market leader in CGM in revenue and in the amount of patients, and we're growing at twice the rate," he said.

Abbott exited 2019 with well over half a million Libre patients in the United States, Ford said. The company's focus in 2020 will be to take advantage of what it has established in terms of the infrastructure and drive demand, he said. So don't be suprised if you start seeing more television ads about Libre, more headlines about sales force expansion, partnerships, and other activities as Abbott tries to sustain the momentum the company saw with the product in 2019.

"And I think that, that same momentum that you see in the U.S. is also there in our international markets, which is obviously a much larger base for us, and we saw great momentum in Q4," Ford said.

Judging from the clinical data Abbott has reported, it's easy to understand why patients are eager to get their hands on the newest version of the blockbuster diabetes tool.

"[Libre] is the most studied CGM right now. And if you look at the data, whether it's our data, whether it's real world evidence data, whether it's third-party government sponsored trials, they all say the same thing, which is people that use Libre have better outcomes," Ford said. "They live better. Their A1c drops. Their hypo drops. Their rate of hospitalization goes down. So that the value proposition that we've always envisioned for Libre not only is it intact, but we actually see it growing. It's an easy to use, intuitive, consumer-friendly product that delivers the outcomes that are real and measurable and it's priced for mass adoption, it's affordable."