The FDA yesterday released information on a panel its holding over Dexcom Inc.‘s (NSDQ:DXCM) G5 continuous glucose monitor, as the company seeks an expanded indication.
The new indication 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.
With all of the data provided for the G5 CGM, Dexcom is likely to win a favorable vote in the panel, according to Leerink Partners analyst Danielle Antallfy.
“In our view, the panel docs are largely benign and support our belief that the panel will vote favorably that the benefits of a nonadjunctive claim outweigh the risks,” Antalffy wrote in a letter to investors. “As a reminder, the importance of a dosing claim centers not only around increased convenience to the patient — potentially further accelerating patient adoption — and validation of the technology, which could drive a higher number of physicians to prescribe, but also the possibility of securing CMS coverage, which would provide access to the 20%+ of Type 1 patients currently covered by Medicare.”
The roster of authorities sitting on the panel will work in Dexcom’s favor as well, Antallfy said, as it includes 6 endocrinologists and diabetes authorities, who the analyst thinks would “likely be more postiively biased towards CGM.”
The federal watchdog announced it would convene an advisory panel to consider expanding the indication for the G5 in May.
The Center for Devices & Radiological Health’s chemistry & toxicology panel said they plan to meet July 21 to recommend whether the intended use for the Dexcom G5 should be changed so that diabetics can use it to replace finger-stick blood glucose monitoring; the G5 device measures glucose using the interstitial fluid surrounding cells just under the skin.
The FDA’s August 2015 approval for the Dexcom G5 came months ahead of expectations; the device won CE Mark approval in the European Union less than a month later. Last March Dexcom said it made the G5 compatible with Apple’s (NSDQ:AAPL) Apple Watch, but warned in Aprilof possible alarm and alert malfunctions with the G5 and 1 of its predecessors, the G4 Platinum.
