new now next January 28, 2012

FDA Approves Bydureon, a Novel, Once-Weekly Diabetes Therapy for Type 2 Patients

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Bydureon, a once-weekly version of the GLP-1 Byetta, was recently approved by the FDA.

On January 27, the Food and Drug Administration (FDA) granted approval to Bydureon, a new drug for type 2 diabetes that is injected once a week. Approved last year in Europe, and now approved in 31 countries and available in 10, the drug should be available in US pharmacies by mid-February of this year. Bydureon’s approval comes after a series of regulatory setbacks, as the approval was initially expected in 2010; but the FDA denied the drug on two occasions because of concerns about its label and about its effect on heart rhythms. These concerns were put to rest by a clinical trial of very high doses of exenatide (the active ingredient in Bydureon), in which the drug was shown not to significantly affect heart rhythms. That European regulatory authorities had also approved the drug also made it more likely it would be approved here in the US, and indeed, the third time was the charm. We had the opportunity to test the delivery device in Europe, where Bydureon has been approved since last June, and we describe our experience in the NewNowNext of diaTribe #36. For more information on the development of Bydureon, see the Learning Curve in diaTribe #26.

Bydureon belongs to a relatively new class of diabetes drugs called GLP-1 receptor agonists, first approved in 2005, which stimulate the body to produce insulin only when blood glucose levels become too high. Like other approved GLP-1 agonists, Bydureon provides glucose control (A1c reduction of 1.3%-1.9%), with the potential for weight loss (typically about six pounds), and no increased risk of hypoglycemia or need for dose adjustment. In particular, the combination of no hypoglycemia and weight loss in most patients (rather than weight gain, as is commonly seen with insulin and TZDs), have made this class very appealing to doctors and healthcare educators (see the Learning Curve in diaTribe #24 for more details).

Bydureon is the third GLP-1 receptor agonist to reach the US market, after Byetta in 2005 and Victoza in 2010. While Bydureon and Byetta share the same active ingredient (exenatide), Byetta is typically injected twice a day whereas Bydureon uses “microspheres” that degrade slowly in the body allowing for once-weekly dosing (this short film clip by the manufacturer explains how this works here). In addition to added convenience, Bydureon has shown greater reductions in A1c than Byetta and significantly lower rates of nausea and vomiting. One disadvantage of Bydureon, compared to both Victoza and Byetta, is that it uses a larger needle (23 gauge and just under 8 mm long for Bydureon vs. 32 gauge and 4 mm long for Byetta and Victoza) and requires reconstitution (mixing the drug with a liquid) before its use. New versions of Bydureon that do not require reconstitution are currently in development, and we expect a “Bydureon pen” by early 2013.

In the meantime, if you have type 2 diabetes and are looking to improve your glucose management, you can ask your doctor about Bydureon. For those paying out of pocket, Bydureon will be $31 per month more expensive than Byetta ($323 vs. $292), but will be slightly less expensive than the highest dose of Victoza. The higher price relative to Byetta makes sense to us since it’s more expensive to make and took substantial resources to develop and get approved; we expect insurance coverage in the US to be good, for those lucky enough to have insurance. As we understand it, the manufacturer of Bydureon plans to offer a co-pay savings program (up to $50 per month for two years) for certain eligible patients.

We applaud the approval of Bydureon in the US and believe that many people with diabetes will appreciate the convenience of once-weekly dosing. Some patients may still prefer the smaller needle size and once-daily dosing of Victoza, at least until a pen is available – only time will tell. Because it is more rapid-acting, Byetta (taken twice daily – or even three times daily by some) may continue to be preferred by some patients, in combination with basal insulin to control glycemic spikes after a meal. We welcome the fact that patients now have multiple GLP-1 options, and we look forward to diaTribe’s Test Drive on Bydureon, coming soon! –MY

FDA Denies Approval of New Diabetes Drug dapagliflozin

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SGLT-2 inhibitors cause users to excrete excess glucose through their urine.

Earlier this month, the FDA chose not to approve Bristol-Myers Squibb/AstraZeneca’s dapagliflozin, a member of a class of drugs that causes users to excrete excess glucose through their urine (SGLT-2 inhibitors; see Learning Curve in diaTribe #24). This decision was somewhat expected, given that an outside panel of experts (an “advisory committee”) assembled by the FDA in July 2011 believed that the potential risks of the drug currently outweigh its benefits. As a reminder, the experts on such advisory committees recommend approval/non-approval of a new drug based on the available data from clinical trials to date (see our NewNowNext in diaTribe #35). The FDA then considers the votes and discussion from these advisory panels in its decision to approve the drug. Following the official announcement of non-approval earlier this month, Bristol-Myers Squibb/AstraZeneca have remained rather vague about what the FDA is requesting from them before reconsidering the drug’s approval; for now, the companies have only noted that the agency does indeed want to see additional clinical trial data. It seems likely that the FDA is concerned with the potential cancer risk of dapagliflozin, as late-stage trials uncovered possible increases in the risk of bladder cancer (0.3% of men treated with dapagliflozin versus 0.05% with placebo [inactive pill]) and breast cancer (0.4% versus 0.1% of women). In addition, while the advisory committee seemed confident that the increased frequency of urinary tract infections with dapagliflozin (a characteristic of most SGLT-2 inhibitors in development) could be adequately managed with careful monitoring and antibiotics, it is possible the FDA was not as comfortable and wanted to see better risk management strategies prior to approving the drug. –VW

Sanofi/AgaMatrix’s New iPhone-Compatible iBGStar Glucose Meter Cleared by FDA

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The iBGStar, the first iPhone-compatible blood glucose meter, is now approved for use in the US.

Recently, we were excited to hear that Sanofi/AgaMatrix have received FDA clearance for the iBGStar, the first blood glucose monitor that connects directly to an Apple iPhone or iPod touch. We first wrote about the iBGStar in NewNowNext in diaTribe #25 when it became available in Europe. As a reminder, the meter is about the size of a USB memory stick, attaches to the iPhone or iPod touch through a built-in dock connector, and uses technology from AgaMatrix. When the iBGStar is plugged directly into the Apple device and a user tests his or her blood sugar, the screen displays the test result using the iBGStar Diabetes Manager App. (Once the meter is on the market, users will be able to download the app for free in the iTunes App Store.) The iBGStar also has a small screen on the device itself, allowing it to be used independently of an iPhone or iPod to measure blood glucose levels. Results are synchronized the next time it is plugged in to an Apple device. We look forward to the launch of this innovative meter in the US, though Sanofi has yet to disclose a timeline.

Besides the small size of the meter, the iBGStar’s key innovation is the simple transfer of blood glucose readings to the well-designed iBGStar Diabetes Manager App. As we understand it, the application will be very similar to the WaveSense Diabetes Manager (designed by Sanofi’s partner AgaMatrix and currently available in the iTunes App Store) – it includes a logbook, trend chart, color-coded screen alerts, and carbohydrate/insulin tracking in a sleek user interface. Other features include the ability to email information to family members/healthcare professionals, and the ability to tag individual blood glucose readings (food, exercise, medicine, or health issues). In the future, Sanofi may integrate an insulin-dosing calculator for Lantus into the iBGStar Diabetes Manager App – we first heard this at a Sanofi corporate presentation in September of last year. Ideally, an integrated Lantus calculator would enable better data recording and potentially, more optimal dosing. –AB

Medicare to Cover Obesity Prevention Services

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In late November, the Centers for Medicare and Medicaid Services (the federal agency that administers the two public insurance programs) announced that Medicare would begin covering obesity prevention services. Under the new benefit, Medicare beneficiaries are eligible to receive free obesity screenings, and individuals identified as obese (a Body Mass Index of 30 kg/m2 or greater) are also eligible for free obesity counseling in primary care settings. The counseling consists of weekly face-to-face sessions with a primary care provider for the first month and bi-monthly face-to-face sessions for the next five months. Individuals who lose at least six-and-a-half pounds of weight over this period will also qualify for an additional six months of counseling. The counseling services covered under the benefit include diet assessments, behavioral counseling, and behavioral therapy. However, weight-loss medications will not be reimbursed. The benefit is part of a collection of preventive services now covered by Medicare under the new healthcare reform bill (Affordable Care Act). Although the benefit has some limitations (e.g., counseling by dieticians and behavioral psychologists will not be reimbursed; counseling is limited to one year), with approximately 30% of Medicare enrollees now obese, it represents an important step in our nation’s efforts to address the growing obesity epidemic. In the coming years, we look forward to tracking the success of this program within the Medicare population, and we hope to see Medicare’s actions spur other large insurers to adopt similar obesity prevention policies. –BK

Promising New Developments for Vivus’ Weight-Loss Drug Qnexa

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As we have previously written, Vivus’ weight loss drug Qnexa is up for approval in the US in April of this year. Encouragingly, Vivus announced recently that, if approved, Qnexa could be available for use by a broader population than previously anticipated. In October 2010, the FDA chose not to approve Qnexa because of concerns over potential long-term safety issues, including a risk for birth defects (teratogenicity) – see the NewNowNext in diaTribe #26 for more details. In response, Vivus started a study dubbed FORTRESS to better understand the risk, and this is the main study the FDA will use to assess benefit-risk related to the birth-defect concerns. In efforts to make Qnexa available sooner, Vivus resubmitted the drug to the FDA in October 2011 for use by men and women unable to get pregnant who are either obese or overweight with one or more other medical problems (i.e., diabetes, high cholesterol, high blood pressure) – which would account for an estimated 80 million adults in the US. Earlier this month, shortly after Vivus released preliminary results from FORTRESS (in late December 2011), the FDA asked the company to add women of childbearing potential (except pregnant women) to its proposed population for Qnexa use – an encouraging sign that may indicate the FDA now believes the benefits of the drug outweigh its risks. Even so, these recent developments are by no means a guarantee that Qnexa will gain approval. The FDA will host a meeting to discuss the benefits and risks of Qnexa on February 22 and is expected to make its decision whether or not to approve the drug by April 17. –VW

FDA Approves Medtronic mySentry, Allowing Parents and Caregivers to See Real-Time Insulin Pump and Glucose Trend Information from Another Room

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Medtronic’s mySentry allows caregivers to see real-time insulin pump and CGM information from another room

Earlier this month, Medtronic announced that FDA has approved mySentry, a remote monitoring system that enables parents and caregivers to see real-time insulin pump and CGM information from another room – this should be a welcome tool for parents of children with diabetes who worry about severe nocturnal hypoglycemia, or for caregivers of patients who are less aware of hypoglycemia. The device is approved for use with the MiniMed Paradigm Real-Time Revel insulin pump (see our Test Drive in diaTribe #23) and has two main components: a monitor that displays CGM and insulin pump information (e.g., at the bedside of a parent or caregiver) and the ‘outpost’ that relays information from the insulin pump to the monitor (e.g., in a child’s bedroom). The monitor has a sharp-looking color screen that displays the most recent sensor glucose value in large font, CGM trend arrows, and status information (insulin pump status, battery life, insulin remaining, and time until next sensor calibration and change). The icons on the display are color coded green, yellow, and red, which should give sleepy parents and time-pressed caregivers a quick and easy way to know what’s going on.

The Medtronic mySentry is immediately available to US customers who have a prescription. The $3,000 mySentry is unfortunately not covered by insurance at this time, although we believe that “exceptions” will begin to be granted with documentation. To ease the financial burden, Medtronic is offering it at a 20% discounted launch price of $2,400, with a further $500 discount for new Real-Time Revel pump/CGM users. As we understand it, Medtronic is currently in active discussions on the reimbursement front and evaluating studies to demonstrate the benefits of mySentry. While we do believe insurance companies will eventually pay for the device, it’s unclear how long this will take or what level of evidence will be needed.

In a 35-family user evaluation study (2011) conducted by Medtronic, feedback was very strong, and virtually all families found the device to be valuable. A reported 100% of parents surveyed believed that the mySentry alarms and alerts were loud enough to hear while sleeping at night, over 90% of mySentry users surveyed would recommend mySentry to other parents or caregivers, and 100% of parents surveyed reported that mySentry was easy to use. While such surveys may not be typical, we believe that a significant number of parents would like and use the device if they could afford it. A quote from a highly respected Medtronic engineer and type 1 parent Lane Desborough after his experience with the device said it all: “The two worst days of my life have been (1) when my son Hayden was diagnosed and (2) when we had to return the mySentry from my personal testing of the device.” –For those interested in learning more about the mySentry, we suggest visiting the product’s website at http://www.medtronicdiabetes.net/mysentry. –AB

Partnership for a Healthier America Continues to Make Incremental Progress in the Fight Against Childhood Obesity

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We had the privilege of attending the inaugural Partnership for a Healthier America (PHA) Building a Healthier Future Summit in late 2011 in Washington, DC, where we heard First Lady Michelle Obama speak. Although this was a relatively small meeting, it was very exciting and we were encouraged to hear about the organization’s progress in the fight against childhood obesity. PHA, a nonpartisan organization started in partnership with First Lady Michelle Obama’s Let’s Move! initiative against childhood obesity, is focused on reducing childhood obesity through collaborations with the private sector and other organizations (see diaTribe Dialogue in diaTribe #35 for our interview with PHA President and CEO Larry Soler and PHA Chairman Dr. James Gavin III). At the summit, new PHA-endorsed commitments were announced with a handful of companies and organizations, including Hyatt (to improve the nutritional content of its kid’s and full menus), Kaiser Permanente (to promote breastfeeding for its patients and employees), and the YMCA (to improve health and nutrition in its early childhood and after-school programs). While cynics might say several healthier items on a hotel menu isn’t nearly enough, we at diaTribe believe that any change in the right direction is better than none.

At the meeting, it became apparent that PHA is about taking incremental steps in the right direction here and now. The goal of the organization is not to address or discuss the larger policy issues that could reduce childhood obesity on a national scale (e.g., agricultural subsidies and school food nutrition standards); rather, the organizationPHA will focus its efforts on incrementally beneficial commitments – understandably so, since large policy changes seem unlikely in today’s gridlocked Washington. To close the conference, PHA Honorary Chair Michelle Obama emphasized that everyone, from individuals to large corporations, can play a role in the fight against childhood obesity, and that change will come from the bottom up. –VW

How Type 1 Diabetes Makes You Stronger

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Welcome to Type 1 (W2T1) is a new website featuring engaging and inspiring videos about type 1 diabetes.

Recently, the website Welcome to Type 1 (W2T1; http://www.welcometotype1.com) posted an entertaining and thought-provoking three-minute video to answer the question, “How could getting type 1 make you stronger?” The creators, Dr. Jonathan White and Oliver Brown, take a positive spin on type 1 by emphasizing the valuable life lessons diabetes management can teach us. We were really taken. The site has some great video profiles of people with type 1 diabetes, all intended to give a proactive, inspiring outlook on diabetes. A full-length documentary is also in the works and will be distributed at hospitals, clinics, and by sponsors around the world. We had a chance to meet Dr. White at the International Diabetes Federation’s 21st World Congress in Dubai and were very impressed with his passion and commitment to W2T1. We wish the team the best of luck in their quest to raise awareness and shed positive light on type 1 diabetes. We also encourage readers to see the video – it’s fantastic. –DZ/AB/KC

Insulin Nation All-Digital Magazine Launches, Aggregates Diabetes Content from around the Web

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The front cover of Insulin Nation, an all-digital magazine that launched this month.

A new all-digital magazine, Insulin Nation, launched this month at http://www.insulinnation.com/. The free interactive magazine will be available online and through mobile apps (currently on currently on Android, iPhone, and iPad; Kindle Fire coming soon). We think the most important feature of the magazine is a section called, “The Buzz,” which aggregates influential social media content about diabetes from a variety of sources around the web into a convenient and frequently updated interface (about twice a week for now). Insulin Nation also features original content and videos integrated right into the magazine – we particularly enjoyed the first issue’s profile of Andy Holder, an ironman triathlete with type 1 diabetes. Editor-in chief Chris Leach was inspired to create the magazine after attending a Taking Control of Your Diabetes (TCOYD) conference and meeting Dr. Steve Edelman (who’s also a diaTribe advisory board member – we can definitely see why he was so inspired). We encourage readers to take a look at the first issue of Insulin Nation. –AB/KC