FDA panel votes in favor of Dexcom G5 dosage label expansion

An FDA panel evaluating Dexcom’s G5 continuous glucose monitor seeking a non-adjuctive dosing claim voted in favor of the indication, with 8 votes for and 2 votes against.

The panel voted on 3 separate questions during the evaluation.  On whether or not there is reasonable assurance that the G5 is safe for its proposed indications for use, the panel returned 8 votes for and 2 against.

The panel returned 9 votes in favor and 1 vote against when considering whether or not there is a reasonable assurance that the G5 is effective for the proposed indications, and 8 for and 2 against when asked whether the benefits of the G5’s proposed indications outweigh the risks, according to a Leerink Partners letter to investors.

The company will have to wait to receive an official indication expansion from the FDA, but will do so now with the support of the panel vote.

The new indication would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them.

On Tuesday, the FDA released information for the panel as Dexcom sought the expanded indication for the G5 that would allow the next-gen CGM to replace fingerstick blood glucose testing, as opposed to operating as complimentary to them.

The agency said that the accuracy of the G5 CGM was “close to, but not as good as, traditional self-monitoring blood glucose meters,” but touted that the G5 provides “contextual information and self-monitoring [that] self monitoring blood glucose meteres do not provide that may lead to users making more informed insulin dosing decisions,” according to the report.

To support the use of the device under the new dosage labeling, Dexcom provided clinical data from trials of its G4 CGM, which uses an identical glucose sensor and algorithms.

Reports from the device were found to be within 15% of standard blood sample readings in pediatric patients 81% of the time and for adult patients 86% of the time. The reports were within 20% in 91% and 93% of pediatric and adult patients respectively, and within 30% 96% and 98% of the time, respectively.

“Significant numbers of Continuous Glucose Monitoring System users are believed to be currently using glucose values obtained from their Continuous Glucose Monitoring System devices (“off label” use) to make insulin dosing decisions. 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 FDA wrote in the prepared panel information.

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