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.”
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.
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