UPDATED July 22, 2016, with comment from Dexcom.
An advisory panel recommended today that the FDA grant Dexcom‘s (NSDQ:DXCM) bid for a non-adjuctive dosing claim for its G5 continuous glucose monitor voted in favor of the indication.
The panel voted 8-2 on the safety question, 9-1 on the effectiveness question and 8-2 that the benefits outweigh the risks, according to a Leerink Partners note to investors.
The FDA is not bound by its advisory panels’ votes, but often heeds their advice in making its decisions.
The new indication would allow the next-gen G5 CGM to replace, rather than complement, fingerstick blood glucose testing.
“This recommendation is a big milestone for people with diabetes,” Dexcom president & CEO Kevin Sayer said in prepared remarks. “The diabetes community turned out in force to support this decision. We commend the FDA for bringing this important subject into a public forum, and thank the panel members, as well as the public speakers for their willingness to participate. We look forward to continued positive discussions with the FDA as we seek the agency’s approval of our application.”
Earlier this week, the FDA released information for the panel, saying that the accuracy of the G5 CGM was “close to, but not as good as, traditional self-monitoring blood glucose meters.” Still, the federal safety watchdog said that the G5 provides “contextual information and self-monitoring [that] self monitoring blood glucose meters do not provide that may lead to users making more informed insulin dosing decisions.”
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 the same algorithms.
The G4 was 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.
“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 agency said.
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