FDA panel docs upbeat ahead of Dexcom panel

Dexcom's G5 continuous glucose monitor.

The FDA appears to be leaning toward a favorable outcome for Dexcom’s ($DXCM) PMA of its G5 continuous glucose monitor, which is scheduled for review by a regulatory agency panel this Thursday.

Dexcom is looking to gain approval for the device so that information it gathers from a patient can be used to administer insulin without the standard fingerstick-based blood reading. If approved by the agency, analysts have said Dexcom could eventually be positioned to gain Medicare coverage and increase use of the device by as much as 23%.

According to FDA briefing documents released Tuesday, the agency said the level of accuracy of the G5 is “close to, but not as good as, typical self-monitoring blood glucose meters in the U.S. market.”

Webinar

How ICON, Lotus, and Bioforum are Improving Study Efficiency with a Modern EDC

CROs are often at the forefront of adopting new technologies to make clinical trials more efficient. Hear how ICON, Lotus Clinical Research, and Bioforum are speeding database builds and automating reporting tasks for data management.

Yet, the agency said, “the Dexcom G5 Continuous Glucose Monitoring System provides contextual information that self-monitoring blood glucose meters do not provide that may lead to users making more informed insulin dosing decisions, and which in turn may allow for better glucose management and outcomes.”

Many patients who use CGM systems likely use glucose values from those devices--off-label use--in making decisions relating to their insulin dosing, it said. 

“A significant barrier to these users making better, informed decisions using glucose data from their Dexcom G5 Continuous Glucose Monitoring System device is the labeling restriction currently in place that this device is only to be used adjunctively,” the agency wrote.

As it stands now, the G5 is approved to measure glucose in interstitial fluid as an adjunctive device to complement, not replace, information obtained from blood glucose monitoring devices.  Dexcom is looking for the agency to let patients use the device without the confirmation of a finger stick before treatment.

The G5 CGM system includes a glucose sensor, a transmitter that sends the information to a device, and a receiver that displays the glucose information that can also be sent to a mobile device using a Dexcom app.

Jefferies, an investment banking firm, said it surveyed 50 endocrinologists, of which 73% expect a vote in favor of the non-adjunctive label. Jeffries has put a “buy” rating on Dexcom stock.

The company said it will hold a conference call Friday morning to discuss the outcome of the meeting with the FDA panel.

- check out the FDA briefing documents
- here’s Dexcom’s release

Related Articles:
Google’s Verily, Dexcom aim to launch mini glucose monitor in 2018, with next-gen by 2021
DexCom, Tandem Diabetes pursue combined CGM/insulin pump
Dexcom and Nick Jonas raise their voices for diabetes awareness

Suggested Articles

AstraZeneca is linking up with DeepMatter, a big data firm focused on achieving reproducibility in chemistry, to help improve its compound synthesis.

The $210 million fund began life by leading a $17 million series A round in Quellis Biosciences.

The nine-story building will house Amgen’s Bay Area employees when it opens early in 2022.