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.
AstraZeneca recently announced the European Medicines Agency has accepted the Forxiga application for the treatment of T1DM. Of note, AZ filed with 52-week DEPICT-1 data but only 24-week data from DEPICT-2. FDA filing for Farxiga in T1DM remains projected for H2 ’18.
Biocon has reported that FDA issued a form 483 with six observations for its Malaysian facility. Recall, this facility is primarily responsible for the manufacturing of insulins including its biosimilar glargine. Biocon did not provide further details into the FDA observations.
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.
The FDA advisory committee voted overwhelmingly in favor that Novo’s Victoza CVOT, LEADER, demonstrates liraglutide 1.8mg does not have excess CV risk (19-0) and provides substantial evidence that it reduces CV risk in patients with T2DM (17-2).
The briefing documents for the June 20, 2017 LEADER adcom were posted by the FDA. Recall, Novo Nordisk submitted the sNDA efficacy supplement for Victoza (liraglutide 1.8 mg) on October 25, 2016, which suggests the PDUFA date will be on or around August 25 following a 10-month review.
FDA has issued a Drug Safety Communication regarding an increased risk of lower limb amputations associated with canagliflozin therapies (Invokana, Invokamet, Invokamet XR) based on results from the CANVAS CV outcomes study. As such, FDA is requiring a Boxed Warning to be added to the labels of the respective drugs.
Merck/Pfizer quietly filed their SGLT2i, ertugliflozin, FDC with metformin, and FDC with Januvia (sitagliptin) in December 2016.
EMA has issued a warning that Invokana is associated with increased cases of lower limb amputations, particularly toes, in the CANVAS and CANVAS-R studies. The underlying cause remains unknown. While EMA has concluded the risk exists, the issue remains under investigation with FDA.