As we predicted last December, 2015 saw the release of the Dexcom G4 Platinum with Share receiver, the Tandem t:slim G4 insulin pump, the Dexcom G5 Continuous Glucose Monitoring System, the Medtronic 640G with SmartGuard in Europe, and two novel new insulins (both from Sanofi) – Afrezza inhalable short-acting and Toujeo basal insulin. Also launched in 2015 were Eli Lilly’s Trulicity GLP-1 agonist and Novo Nordisk’s Tresiba basal insulin.
Looking ahead to 2016, we’re optimistic about these seven diabetes products potentially hitting the market in the next 12 months.
Insulet’s Omnipod Phoenix PDM Insulin Pump
At the ADA Scientific Sessions in Boston this June, Insulet teased the crowd with a first look at the next generation controller for their popular patch insulin pump, the Phoenix PDM (Personal Diabetes Manager). The chunky plastic PDM controllers we saw in the UST200 and UST400 models will give way to a sleek, sexy color touchscreen interface. The Phoenix will be thinner than the UST400, black in color, and resemble a smartphone. Though the Phoenix will be Bluetooth-enabled, this PDM will not yet be integrated with the Dexcom G5, though we should see that product quickly on its coattails given that value-added capability.
When might we see the Phoenix rise? In their Q3 earnings call on 5 November, Insulet CEO Patrick Sullivan said they are “on track to submit our Phoenix PDM product to the FDA in the middle of next year, and we would expect to have that on the market or approved by the end of next year.”
Abbott Freestyle Libre Pro Flash Glucose Monitoring System (U.S.)
The Freestyle Libre (consumer version) and Libre Pro (professional HCP-use version) might flash their way stateside in 2016. The first of its kind, the Libre is a factory-calibrated flash system, which means that, rather than continuous display of interstitial glucose readings, the user wears a small sensor in the skin beneath a flat, round, white, disc-shaped transmitter and carries (in the consumer version) a small device that the person can use to scan the sensor and display a reading at any time. Demand has been so high in Europe that consumers report a significant backorder.
Libre’s appearance in the Freestyle pipeline follows Abbott’s long commitment toward out-of-the-box calibration and this author believes it serves as an important proof of concept toward their next generation continuous glucose sensors. (I used their gen1 Freestyle Navigator CGMS for three years and was a big fan.) Our hope here is that Libre paves the way for continued progress in CGM technology from the company.
While Abbott has been tight-lipped about progress to bring Libre to the United States, we do know that the Libre Pro has been submitted to the FDA for potential launch in 2016. The Pro version is meant to be used by health care providers to collect glucose data – which is blinded to the patient – for analysis and treatment changes and would have an easier pathway for reimbursement than the consumer version. As for Libre for home use, we’re still betting here on 2017, though the pivotal study of Libre in the United States was completed in March 2015. Abbott has not historically had the kind of smooth, fast-track relationship with FDA that companies like Dexcom have mastered.
Medtronic Minimed 640G Insulin Pump (U.S.)
The Minimed 640G insulin pump may come to the States by end-of-year 2016, as Medtronic says they plan to submit to FDA early in the new year.
Building on the success of their Low Glucose Suspend (LGS) feature in the 530G model (called Minimed Veo outside the U.S.), the 640G adds predictive LGS capabilities (called SmartGuard abroad) and can suspend and resume basal delivery based on predicted hypos, performing as a semi-automatic closed loop. This is the most revolutionary change in design we’ve seen from Medtronic, with a whole new colored user interface, new buttons, and a portrait orientation – shifting the long-standing insulin pump paradigm from pager to smartphone.
The pivotal trial in the States was completed with Medtronic’s fourth generation sensor (the third in the Enlite series) and they submitted specs to the FCC in February for a transmitter designed specifically for the 600 series pumps (of which 670G will be the next in their pipeline), so we expect to see Medtronic skip the Enlite 2 here in the U.S. entirely and move to this fourth generation sensor in the 640G when it comes to the United States.
Dexcom 6 Continuous Glucose Monitoring System
It wouldn’t be the end of a fiscal year without some speculation on what Dexcom has up its sleeves. If 2015 was the year of the Dex – with two integrated pump partners (Tandem and Animas) and two new products (G4 Platinum with Share and G5), then 2016 is going to be about their building capacity for what’s to come. We’re not going to see them rush too quickly toward G6 approval, especially as G6 supposedly will not require calibration, as Kevin Sayer has said that they have “no intention of ever moving backwards from a non-injunctive claim once we establish it.”
Still, we know that Dexcom surprises even themselves with how quickly they can get product approved and rolled out to customers, with the original G4 Platinum approved within 90 days of submission to FDA. In the meantime, we expect to see a new insertion device for their sensors and hope to learn more about the G5 strengths and opportunities as the long line of customers waiting for Santa Claus to bring them their G5 systems unwrap those tech goodies.
GLP-1 and GLP-1/Basal Combos: Lyxumia, Lixilan, & Xultophy
Sanofi, having brought two new drugs to the US market in 2015 with Mannkind’s Afrezza and their new basal Toujeo, is quickly working to follow that up with their GLP-1 agonist and GLP-1/basal insulin combination drugs in the United States. Sanofi filed for New Drug Appliaction (NDA) with FDA for its GLP-1 agonist Lyxumia (lixisenatide) in September 2015. Once approved, we expect approval for Lixilan (Lyxumia+Lantus) to be right on its heels.
Combination drugs are certainly a big market in type 2 therapies right now. Novo Nordisk’s Xultophy, a combination of their commercially successful GLP-1 agonist Victoza and their brand new basal insulin Tresiba, also had its NDA put in front of FDA in September and will likely beat Lixilan to market. Xultophy is already approved in Europe, but was held up here until its Tresiba component could be approved. We expect to see all three of these GLP-1 drugs available in pharmacies by next year’s end.
Novo’s New Novolog and a Long-Acting from Lilly
Novo Nordisk has another game-changer up its sleeve, as well, having announced just last week that an NDA has been filed for a newer, speedier version of Novolog (insulin aspart) for treatment of type 1 and type 2 diabetes. According to their press release, the “faster-acting insulin aspart contains a short-acting insulin and two well-known excipients, a vitamin and an amino acid, to increase the initial absorption rate and an earlier blood sugar lowering effect.” What does this mean for people with diabetes? Better post-prandial (post-meal) blood glucose control. Bring it on.
Another insulin coming to us in 2016 is Lilly’s new basal insulin, Basaglar – a form of insulin glargine (which you may recognize if you’re familiar with Lantus). FDA approved it just this week after a patent dispute was finally resolved with Sanofi. As stated in the FDA press release, “Basaglar is the first insulin product approved through an abbreviated approval pathway” because it is “sufficiently similar to Lantus to justify reliance.” Lantus’s patent expired in 2015 and it will be interesting to watch glargine’s progress under a competing label. Another note of interest is that Basaglar is not approved as a biosimilar product, as the manufacturer must actually apply for biosimilarity through a specific application process. As Merck and other companies prepare for a rollout of their own forms of insulin glargine in the coming years, we hope that choice in basal insulin therapy will increase for patients and that prices…perhaps…decrease.
In October, we were thrilled to learn that Eli Lilly & Company acquired the rights to Montreal-based Locemia’s novel nasal glucagon. Easy to carry, easy to dose, easy to implement, nasal glucagon will do for people with diabetes what the Auvi-Q has done for people with allergies – make a life-saving, every-second-counts emergency treatment fairly fool-proof to administer.
Will we see it come to market in 2016? We hope so. Locemia had said they planned to submit to FDA in late 2015, early 2016, so it’s our best guess that Lilly might follow a similar timeline.