FDA and Dexcom announced approval of the Dexcom G6 CGM after a notably short 6-month review time, suggesting increased FDA comfort with CGM technology. The new device is the first real-time CGM approved for standalone and interoperable use. Launch is anticipated in Q2 ‘18, and Dexcom is projected to have a significant presence at ADA.
Briefing documents for the Senseonics implantable Eversense CGM were posted today by FDA in advance of the March 29, 2018 adcom. Also of note, FDA today announced approval of the Dexcom G6 and a new lower risk classification of interoperable CGM (“iCGM”). Below, FENIX has analyzed the key issues anticipated to be discussed during the adcom.
J&J announced it has received an offer from Platinum Equity to purchase LifeScan for $2.1B. According to the press release, the acceptance period for the offer ends June 15, 2018 with closing of the deal to occur by YE ’18. Below, FENIX provides insight on the potential opportunity that Platinum Equity may see for the LifeScan business.
During Day 2 of JPM, presentations ranged across both diabetes drug (Sanofi, Lilly, Lexicon, and Mylan) and device manufacturers (Dexcom, Insulet, and Roche), although Mylan and Roche did not discuss their diabetes portfolios. Below, find key takeaways from JPM followed by more in-depth coverage.
Dexcom hosted its Q4 ’17 earnings call and provided updates to its CGM business. Of note, Dexcom disclosed that while they are working with FDA on not requiring calibrations for G6, it will still allow calibrations if the user chooses. Below are highlights from the call.
In light of the recent journal publication of PRECISE II, the US pivotal IDE trial for Senseonics’s Eversense implantable CGM, FENIX has conducted a comparative analysis vs. Abbott Freestyle Libre and Dexcom G5 Mobile, with a particular focus on sensor accuracy across glucose ranges.
It was reported on Twitter that at ATTD 2018, Dexcom displayed a slide (pictured below) showing a representation of a smart insulin pen. Additionally, Dexcom presented information on the “fully enhanced Dexcom G6 CGM system” including “Urgent Low Soon Alerts.”
Glooko announced FDA clearance of its Mobile Insulin Dosing System (MIDS). According to Glooko, the system analyzes FPG and recommends dose adjustments based on a pre-configured HCP plan or published clinical guidelines.
Abbott’s FreeStyle LibreLink is reportedly the first third-party iOS app to utilize Apple’s NFC technology (previously NFC use was limited to Apple Pay). The LibreLink app is believed to currently only be available in Europe, but it is assumed a US version is on the horizon.
JDRF announced a partnership with EOFlow, a South Korean medical device company, to develop a patch pump automated insulin delivery system. EOFlow currently has two diabetes pipeline products including a wearable insulin pump-only (EOPatch) and an artificial pancreas system (EOPancreas).