NewNowNext August 30, 2011
Bydureon Resubmitted for Approval in the US Following Positive Results from a Heart Study
In welcome news, the pharmaceutical companies Amylin, Eli Lilly, and Alkermes announced in early July that Bydureon, a drug for people with type 2 diabetes meant to be injected once weekly, was found to not harm an important aspect of heart function in a recent study. Last fall, the FDA requested that the companies conduct this heart study (called a tQT study) before it would approve the drug for use in the US (see Learning Curve in diaTribe #26). This request had come as a surprise – we had certainly expected approval – and we estimate that by approval, this delay will have cost the company approximately two years in getting the compound to patients. With these results in hand, the companies resubmitted Bydureon to the FDA in late July for approval. Typically, the agency requires six months to review these types of applications, placing the next possible approval date for the drug on or before January 28, 2012. As a reminder, Bydureon belongs to a class of injectable drugs called GLP-1 agonists, which stimulate the body to produce insulin only when blood glucose levels become too high. Two other GLP-1 agonists are currently available in the US (Novo Nordisk’s Victoza and Amylin/Eli Lilly’s Byetta), but in contrast to those drugs, Bydureon lasts longer in the body, allowing the drug to be administered once weekly, and also has a better side effect profile, largely because it causes significantly less nausea than seen with Byetta, the first GLP-1 approved. As we reported last month, Bydureon was approved for use in Europe in June, and people with type 2 diabetes have already begun to use the product in the UK. --BK
FDA Advisory Committee Denies Approval of New Diabetes Drug Dapagliflozin
While the pharmaceutical industry continues to offer new products, it has been over two years since the FDA has approved a diabetes medication with a completely novel drug target. So expectations were high last month when the agency convened its panel of outside experts to discuss Bristol-Myers Squibb/AstraZeneca’s new diabetes medication, dapagliflozin. It’s an SGLT-2 inhibitor, a member of a class of drugs that causes users to urinate out excess glucose (see Learning Curve in diaTribe #24). Though dapagliflozin has been encouraging in effectiveness and its lack of hypoglycemia and weight gain, late-stage trials uncovered possible increases in the risk of bladder cancer (0.3% of men treated with dapagliflozin versus 0.05% with placebo) and breast cancer (0.4% versus 0.1% of women); a single patient on dapagliflozin experienced possible drug-induced liver injury as well, which concerned the FDA. So it wasn’t a surprise that much of the day’s discussion focused on these risks, as we watched from our front-row seats in Silver Springs, MD. Given that the length of drug exposure was not as long as it usually takes a tumor to develop, it wasn’t clear if dapagliflozin was responsible or if some patients may have had underlying cancer before entering the trials. Likewise, with only one patient demonstrating possible drug-induced liver injury, it was difficult for the committee to draw any conclusions. Notably, there was little discussion on the increased risk of urinary tract infections, which many considered one of the biggest drawbacks of SGLT-2 inhibitors – the committee seemed to think infections could be adequately managed with careful monitoring and antibiotics.
In light of the large number of people unable to control their diabetes with current treatments, we were encouraged that many panel members noted the need for new diabetes drugs in clinical practice. But given the possibility of increased risk of life-threatening diseases, the committee concluded in a 9-6 vote that dapagliflozin would not be able to be approved without further data. This follows the very conservative trend at the FDA under the current administration. While the FDA rarely goes against a “no” vote from an advisory committee, the agency is not required to abide by its recommendation. The FDA is expected to make an official decision on dapagliflozin by October 28, 2011. It’s hard to forecast this one, that’s for sure. We here at diaTribe believe that we need more alternatives for people with type 2 diabetes and that the drug should be approved in at least a limited population, with users monitored closely. --VW
Abbott Announces It Will Permanently Discontinue the FreeStyle Navigator CGM in the US
On August 31, Abbott Diabetes Care announced that it will permanently discontinue the FreeStyle Navigator continuous glucose monitoring (CGM) system in the United States. This disappointing news comes on the heels of a supply interruption that has existed since early 2010. Going forward, Navigator will continue to be used in research studies (welcome news for the artificial pancreas) and will also continue to be available in its "next generation" version (one-hour rather than ten-hour warmup time) in Europe and Israel. Based on our discussions with Abbott, we believe the company is working on a 'next-next' generation CGM system in the US. From a commercial perspective, we think it was not worth it for the company to continue to support this product with so few people on it - Abbott didn't ever launch the one-hour system in the US though it was approved in late 2009. The best-case scenario for US patients would be for Abbott to invest in future CGM systems and effectively leapfrog the approved-but-never-launched the Navigator with one-hour calibration. A fairly small number of patients used the ten-hour calibration version, so we do understand it was a lot of investment for few patients. As long as the company does continue to invest in CGM, we will be very happy for patients, though we do feel sorry for those using Navigator who counted on it - among them, some notable diabetes scientists and researchers and their children. More focus on future innovation will be great to see. The worst case scenario for patients would be if Abbott discontinues CGM internationally in the next year-plus. We hope very much not to see this, as some incredible scientists and researchers are in-house at Abbott at work on this technology. --AB/KC
Reata and Abbott Team Up to Develop New Drug for Chronic Kidney Disease
Late last year, we found out about a new drug being developed by Reata Pharmaceuticals for the treatment of chronic kidney disease (CKD), a disorder that occurs more frequently in people with diabetes (for more information about CKD, please see What We’re Reading in diaTribe #8). In the last couple of months, we have learned more about it and seen more data, and we believe this is one that we’ll be hearing about for a long time to come, if current results are seen in larger, phase 3 studies. Why is that? This looks to be a disease-modifying drug – in other words, this drug could significantly improve long-term prospects for people with CKD. Currently, no treatment options exist for CKD beyond controlling high blood pressure and blood sugar levels to prevent the development of irreversible kidney failure. Encouragingly, Reata’s drug candidate – called bardoxolone – was recently shown to significantly improve kidney function in people with type 2 diabetes and CKD in a yearlong phase 2 study (for those interested in reading the study’s full publication that was published in the highly-respected New England Journal of Medicine in June, please click here). Last year, the early impressive results from Reata drew the interest of Abbott (maker of the FreeStyle Lite blood glucose meter and the FreeStyle Navigator continuous glucose monitor), which has decided to team up with Reata to help develop the drug and bring it to market (Abbott will be responsible for work outside the US). The companies are currently recruiting for a phase 3 trial in the US dubbed BEACON, and if all goes well, the drug may become available as early as 2014. Because it’s such an exciting new drug, we’ll be writing a more comprehensive update on bardoxolone in our upcoming issue focused on diabetes complications – stay tuned! --BK
Telcare debuts cellular-enabled blood glucose meter at AADE annual meeting
Telcare's cellular-enabled blood glucose meter will automatically upload a user's test results to an online portal.
Though people with diabetes are urged to keep logbooks or to frequently download their blood glucose meter data, life often gets in the way. Fortunately, new innovations are making it faster, simpler, and more useful than ever to keep track of diabetes data. Soon we’ll start seeing smarter and sleeker meters with more connectivity, more powerful data and trend analysis, and improved communication capabilities with doctors and nurses. One encouraging example comes from a small company, Telcare, which debuted its new cellular-enabled blood glucose meter at the American Association of Diabetes Educators (AADE) annual meeting in August. Although the meter won’t launch until later this year, the company’s AADE booth – which included hands-on demonstrations – generated considerable buzz.
The most exciting feature of this new meter is its 3G wireless connectivity (similar to a cell phone), which allows it to automatically upload a user’s test result to an online portal. The process works as follows: 1) someone tests his or her blood sugar; 2) after six seconds, the test result is displayed in large font; 3) a 20 second countdown timer is initiated during which the user has the option to mark the blood sugar reading one of thirteen “reading tags” such as “before breakfast” or “after activity”; 4) once the timer reaches zero or a reading tag is selected (whichever comes first), the test result is automatically sent to MyTelcare.com, an online portal where people with diabetes and those they authorize (e.g., family, doctors, nurses, educators) can log in, view reports and statistics, and recognize trends. The data upload occurs automatically from the meter itself and requires no additional hardware, wires, or service fees. If a user is somewhere out of a cellular service zone, the blood glucose number, time, and reading tag are all saved in the meter’s memory and can be sent later. Additionally, Telcare will offer free smartphone applications that automatically receive data from the blood glucose meter, create reports, conduct trend analysis, and even incorporate social media sites like Facebook and Twitter. Telcare also has its own social community planned that will be directly integrated into the apps.
Aside from the data upload, one of the meter’s more innovative features is its ability to send messages to the user. After each blood glucose value is sent to the online server, a feedback message appears on screen. When the product is used without a prescription, post-test messages are motivational, such as “You have completed 65% of your targeted tests this week and your glucose is within 30% of target.” (In this case, individuals have input their own target number of tests and target glucose range.) When the meter and targets are prescribed by a health care provider, such as a diabetes educator, physician, or nurse case-manager, the messages can become more medically focused, such as “Good work, Julia. Still a bit above target. Try adding one more unit of insulin before lunch. Testing adherence is 88% this week.” In addition, the meter allows for Q&A with the user, much like the Health Buddy and WellDoc systems. In the demonstration we saw, the onscreen text was phrased in a conversational way and was really quite disarming (note – there is no audio, only words). Keep in mind that the messages can be customized or even turned off – this is important, since we did hear from one person with type 1 that he didn’t want to be told what to do by a meter!
This sort of blood glucose test and trend information strikes us as potentially quite helpful. Diabetes can be isolating, but we think that getting real-time feedback along with the data to contextualize it will be motivating. What’s more, in keeping with the trend of greater electronic contact between doctors and patients, healthcare providers can message or send multiple-choice queries to patients directly on the meter (for example, if they see that many dangerous low or high blood sugars have occurred recently).
The meter can also simplify the complex logistics of diabetes care. For example, if the meter is linked to the healthcare provider’s own electronic scheduling system, the system can automatically send queries such as, “Susan, our records indicate that you have an appointment this Thursday. Please confirm by calling 415 241 9500,” or “Mary, our records show you have not had your annual eye or foot exam this year. Would you like to schedule now? (Y/N).” Additionally, the server keeps track of how many strips people have used, and they can use the meter to reorder supplies by responding to messages, like “Zach, your average BG today is 136 mg/dl. You are running low on supplies. Would you like to reorder? (Y/N).” If yes, the meter then messages Telcare Medical Supply, Inc. (Telcare has a durable medical equipment entity, as well) and supplies are delivered, pending insurance approval. The reimbursement process will be set up in Telcare’s “back office”; in many cases no further documentation or contact would be needed prior to delivery.
Other features of the meter include a color screen, a rechargeable battery, and high accuracy. Interestingly, its high accuracy was what really got our attention to begin with - Telcare’s meter is within 10% accuracy of laboratory measurements 95% of the time, compared with the FDA’s current requirement of 20% (for more information on this topic, please see the Learning Curve in diaTribe #22). This is the first meter we have seen with this level of accuracy that will be in the label – though we expect accuracy to continue to improve across the industry, we were happy to see this prioritized from the start with this meter.
The meter is slightly larger than average (about the size of a Blackberry, and a little thicker), though not bigger than the other larger meters that are used today. It weighs 115 g (4.06 oz), which is less than most smartphones but more than twice as heavy as most leading blood glucose meters. The company will offer 24/7 customer service, similar to other major meter companies.
So what’s not to like? Well, this is a new business model – and people will be able get a free meter only by making a two year commitment to using Telcare’s test strips (and a reduced-price meter only by making a shorter commitment). Those not wanting to make a commitment to test strips will be offered a retail price of around $100. Unlike all of the other wireless strategies we have seen, however, the cellular service fees are included in the price of the test strips, which is good news for customers. As we understand it, the cost for 50 strips will be in the same range as those for current “branded” (not discount) meters. Notably, Medicare will provide reimbursement for strips and for the meter on the same basis as other glucose meters. What does this mean? Medicare will chip in roughly $50 for the first meter, and individuals will pay the balance out of pocket. Private insurers, meanwhile, might also contribute – Telcare is currently in reimbursement discussions with various insurers, payers, and employers.
We really like that this meter will simplify data downloading, enabling people to better understand, contextualize, and control their diabetes. We’re also glad to see Telcare make it easier to involve doctors and nurses — we believe this meter will really help “individualize” therapy, just as recent care guidelines have recommended. On a related note, we also hope to see insurance companies reimburse doctors and nurses for more time spent helping patients manage their blood glucose – short-term investment here may well yield longer-term rewards, and we look forward to seeing data on this front. In the meantime, Telcare itself plans to compensate doctors and nurses for the time it takes them to thoroughly train their patients on the different advanced functions of the meter and web portal. We also hope to see insurance companies reimburse doctors and nurses for more time spent helping people manage their blood glucose so that they are paid for ongoing analysis as well as training. We eagerly anticipate the meter’s launch later this year, and we note that interested readers can enter their email address on Telcare’s website (www.telcare.com) to be informed when it will be available for purchase. We’ll stay tuned for further developments from this company, and we hope to Test Drive the meter once it becomes available. --AB/KC
Disney Discovers Diabetes
Coco, Disney Publishing Worldwide's first character with type 1 diabetes.
In partnership with Lilly Diabetes, Disney Publishing Worldwide has created its first character with type 1 diabetes, a young monkey named Coco. Coco is featured in a new Disney Publishing Worldwide children’s book called, “Coco and Goofy’s Goofy Day.” Coco and Goofy are invited to a birthday party, but concern is raised that Coco shouldn’t go. Coco finds a powerful ally in Mickey Mouse, who agrees that she can “come to the party, play games, and have treats.” At the party, Coco has a wonderful time running around, doing very well in a game of musical chairs, and enjoying a modest-sized piece of birthday cake. Coco’s mom checks her blood glucose and other characters admire her strength. Unlike Goofy, who overdoes it by stuffing his face and being generally lazy, Coco practices moderation and is still going stronger than ever at the end while Goofy has to be brought home in the wagon he thought Coco might need because of her diabetes (right!). The book ends with a question and answer section that gives children and adults alike the opportunity to learn more about diabetes. (For example: “What does Coco carry in her backpack?”) Coco’s story is part of a collection of custom books for children of various ages and stages of life with diabetes: a cookbook is in the works, and there will be an “Expert Advice for Guests with Type 1 Diabetes” addition to the Birnbaum Guide to Walt Disney World “Pocket Parks Guide” series, which will have an introduction by Children with Diabetes co-founder Laura Billetdeaux. This exciting news was introduced at Disney World mid-summer at the CWD Friends for Life conference, and the man who runs diabetes at Lilly, Enrique Conterno, was there himself – a notable sign of Lilly’s commitment. To boot, Lilly used social media to introduce the news (they announced it first at Friends for Life to members of the diabetes online community and let it catch on through Twitter and Facebook – we think we were the first to Tweet this – @diaTribenews), and followed up several weeks later with a contest about type 1 diabetes and family life – see here to enter, and do so by November 30, 2011! If your essay is chosen, you will win a trip to Friends for Life in 2012! --JGS/KC
FDA Drafts Guidance on Mobile Applications
According to a recent Apple report, over 425,000 mobile apps are now available in the App Store, with a staggering 200 million users and 15 billion downloads. And recent reports show explosive growth in use of Google’s Android operating system, with over 550,000 new activations every day. The ubiquitous presence of mobile applications is not limited to games, however, as there are growing numbers of apps for medical conditions such as diabetes (there were over 700 at time of the recent ADA!). With this in mind, it’s not surprising that the FDA recently released a draft guidance document (the agency’s current thinking on a particular topic) detailing how it will apply regulatory requirements to a certain subset of mobile applications. The agency’s much-anticipated guidelines left many questions unanswered, but did confirm and extend a regulatory framework for mobile apps that diagnose or treat diseases, and applications that connect to other medical devices. Where the FDA hasn’t yet claimed a regulatory role, but reserves the right to do so, is with apps that help people track and manage their health through data manually (or automatically) entered by the users, including identifying glucose patterns and improving overall management. One much-anticipated application for people with diabetes in this space is from Massive Health, a startup company currently running a closed beta test with iPhone users (Massive Health first opened the beta to diaTribe users and we advertised it on Twitter for 24 hours before it filled up – in the future, if you’d like to participate in chances like this, follow @diaTribenews and @MassiveHealth). From what we've seen of Massive Health's app, it seems easy to use, and even fun and entertaining. Other applications in this category offer treatment recommendations to patients, like WellDoc’s DiabetesManager (see NewNowNext in diaTribe #25). General health and wellness apps (e.g., exercise suggestions, calorie counters, or “brochure ware,” like the new myMedtronic Connect app) will not be subject to FDA oversight or regulation.We’ve previously covered apps that will now clearly be regulated, such as AgaMatrix/Sanofi’s iBGStar (a self-contained blood glucose meter that plugs into the iPhone; see NewNowNext in diaTribe #25). Because the app directly reads data from a medical device, it requires FDA approval before marketing. We’ll look forward to helping cut through what apps might help different groups of people with diabetes, their caregivers, and their families in future issues. --AB/KC
Valeritas Receives CE Mark Approval for Its V-Go Disposable Insulin Delivery Device
Valeritas’ V-Go Disposable Insulin Delivery Device.
In late July, Valeritas announced it had received CE Mark approval for its V-Go disposable insulin delivery device, allowing the product to be sold in Europe. We last wrote about the device in December 2010, when the V-Go received FDA clearance in the United States (see NewNowNext in diaTribe #28). While the timeline for launch in Europe has not been disclosed, the company has stated its intent to launch the V-Go in the US before the end of 2011. The device uses a non-electronic, mechanical system to deliver basal-bolus therapy for 24 hours (at which point it must be replaced). Although it sounds like an insulin pump, it’s better thought of as a substitute for people currently using vials/syringes and pens. The V-Go automatically administers rapid acting insulin (Humalog or Novolog) at a preset basal rate and also allows users to deliver two-unit boluses by a two-step button push that can be done through clothing. Given these features, it comes as no surprise that the V-Go was designed primarily for people with type 2 diabetes. In our view, the V-Go’s ease-of-use and discretion should be major advantages. We certainly believe people with type 2 diabetes need more insulin delivery alternatives, particularly since many are not close, on average, to being at suggested glycemic targets and because fewer people with type 2 diabetes take insulin than could benefit from it. --AB
Pfizer Begins Marketing Biosimilar Insulin Products in Partnership with Biocon in India
In October 2010, Biocon, an Indian pharmaceutical company, and Pfizer partnered to develop and market biosimilar insulin analogs (see NewNowNext in diaTribe #26). A biosimilar is a “generic” version of a drug that is made via a biological process (for example, a strain of bacteria is used to make Sanofi’s Lantus [insulin glargine]). This past month, Biocon announced an important milestone in the agreement: Pfizer will begin marketing biosimilar versions of Lantus and regular human insulin in India.
While this may not seem important for US consumers, it’s a sign of things to come, as the patents for Lantus, Novolog, and Humalog all expire around 2015 in the US. Once these patents are up, companies like Biocon and Pfizer would be able to sell biosimilar insulins in the US if they are approved by the FDA. That’s a big if – we do note that the FDA has not yet established a clear regulatory pathway for biosimilar products, although the agency does appear eager to make this possible. The main advantage of biosimilar insulin will be its lower cost. As an example, Biocon’s insulin glargine product currently sells at a 40% discount to Lantus in India. We’re certainly eager to hear further details about this partnership, especially as 2015 approaches. According to a recent dQ&A survey (thank you to all who participated!), a majority of people with diabetes would “definitely” or “certainly” try biosimilar insulin, although most wanted it verified that it really was “the same” as the current insulin they used. Interesting days ahead on this front… --AB
Children with Diabetes and the Diabetes Scholars Foundation
At the recent Children with Diabetes (CWD) Friends for Life (FFL) conference at Disney’s Coronado Springs Resort in Orlando, Florida, we had the privilege of attending an inspiring fundraiser for the Diabetes Scholars Foundation. The Foundation funds multiple scholarships for families and young adults to attend the CWD FFL conference each year in July in Orlando. The Foundation also funds college scholarships ($1,000-$5,000) for high school seniors who have type 1 diabetes.
For those who are unfamiliar, FFL is the largest annual CWD conference and one of our favorite (by far!) conferences every year. Every summer, over 3,000 attendees have the chance to meet other families with diabetes, hear from some of the sharpest minds in the field on topics like the artificial pancreas, cure-focused research for type 1 diabetes, daily care, and hear from celebrities with diabetes like former NFL player Kendall Simmons, who earned two Super Bowl rings playing for the Pittsburgh Steelers – with type 1 diabetes, American Idol Crystal Bowersox, and IndyCar driver Charlie Kimball. The conference caters to the entire family, with programs for teens, tweens (10-12 years), elementary-age children (6-9 years), siblings, and grandparents, with childcare for children up to five years old. Adults with type 1 diabetes have a growing program as well. We encourage readers to get involved with the Diabetes Scholars Foundation and Children with Diabetes conferences by applying, fundraising, volunteering, or attending next year’s Friends for Life. For more information, visit www.childrenwithdiabetes.com and http://www.diabetesscholars.org. --AB/KC
The College Diabetes Network
The diaTribe team was excited recently to meet Christina Roth, the compelling President and Founder of the College Diabetes Network (CDN). CDN's mission is to improve the health, well-being, and longevity of students with type 1 diabetes through social support on campuses, helpful information, and resources for parents. If you have diabetes and are in college, or remember being in college… well, you remember how hard that can be. Currently, CDN has established chapter networks at 18 colleges and universities (Harvard, Penn State, Northern Illinois University, Texas A&M, Texas Tech, Trinity College, UConn, University of Massachusetts – Amherst, University of Wisconsin – Madison, American University, Hampshire College, Johns Hopkins University, Ohio College of Podiatric Medicine, University of British Columbia, Curry College, Boston College, Temple University, and Dartmouth), with plans to expand to many more soon. If your school (or for parents, your son’s or daughter’s school) already has a chapter, please get involved by visiting the website at www.collegediabetesnetwork.org. Otherwise, contact Christina Roth at croth@collegediabetesnetwork.org for more information about starting a new chapter. Everyone at diaTribe who has diabetes and didn’t have this in college sure wishes they had… --AB/KC
Pharmacy Benefit Management Companies, Express Scripts and Medco Health Solutions, to Merge
In late July, pharmacy benefit managers (PBMs) Express Scripts and Medco Health Solutions announced their plans to merge. As background, PBMs process prescriptions for payers (e.g., insurance companies), using their size to negotiate deals and discounts with pharmacies and drug companies. If the Express Scripts/Medco merger goes through, they are expected to process prescriptions for about 135 million people – over one-third of the US population, more than any other PBM. It remains unclear what impact the merger will have on drug prices and prescriptions for people with diabetes. On the one hand, Express Scripts/Medco Health Solutions’ combined size might allow them to bargain with drug makers for lower prices and pass those savings on to consumers. However, because both companies emphasize efficiency and the use of generics, people receiving prescriptions through Express Scripts and Medco might also face more pressure to use mail-order services and generics. While generics (e.g., sulfonylureas, metformin) play an important role in diabetes management and keeping healthcare costs down, they are not always able to bring about adequate (to say nothing of optimal) control of blood sugar levels for people with diabetes. We are not fans of Medco’s mission to have more patients use generics because we think this makes it more difficult for doctors and nurses to individualize treatments. -–LR/KC