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On June 27, the FDA approved Arena Pharmaceutical’s weight-loss drug Belviq (lorcaserin), the first weight-loss drug to be approved in the US in 13 years. Belviq is authorized for use in conjunction with diet and exercise in obese adults (body mass index [BMI] of 30 kg/m2 or greater) or overweight adults (BMI of 27 kg/m2 or greater) with at least one weight-related condition (i.e., high blood pressure, type 2 diabetes, etc.). The drug comes in pill form and is taken twice a day. According to Arena, it will take at least four to six months to receive approval from the Drug Enforcement Agency (which evaluates the potential for drug addiction) to launch the drug, so we expect a launch date in late 2012 or (more likely) early 2013.
Belviq’s approval reverses the FDA’s decision, in October 2010, to reject the drug under a different name, Lorqess (see new now next in diaTribe #26). At that time, the FDA was concerned about the development of breast and brain tumors in mice and rats treated with the drug. Since then, results from additional studies and analyses that Arena has performed have made the FDA more confident in the drug’s safety, as its cancer risk was found to be lower than initially believed.
While a notable step forward for the treatment of obesity and overweight, several experts (including Dr. Arya Sharma of the University of Alberta in Edmonton, Canada) have suggested that Belviq will unlikely represent a ‘magic bullet’ for the obesity epidemic. In the drug’s clinical trials, only modest weight reduction was observed - an average of 3-4% total body weight loss after one year of treatment, though this is “average” and some patients experienced more weight loss and some less. In people with type 2 diabetes, a recently published study found that approximately 45% of participants lost 5% or more of their body weight over a year (approximately 11.4 lbs.). Notably, the trial also found that treatment with Belviq significantly improved blood glucose control (average A1c reduction of 1.0%) – although it’s unclear whether Belviq was completely responsible for this benefit since diabetes medications could be adjusted in the study.
In the future, there is considerable excitement surrounding the use of Belviq in combination with other weight-loss drugs to provide greater weight loss. The safety and efficacy of this use of Belviq, however, has not yet been studied and is not currently approved. We hope such studies will be initiated in the near future. The most common side effects observed with the drug include headache, dizziness, back pain, nausea, and fatigue, and some individuals with type 2 diabetes treated with Belviq experienced hypoglycemia (low blood sugar).
Vivus’ obesity drug Qnexa is next in line for FDA approval on July 17; the drug has demonstrated better tolerability and efficacy than Belviq in clinical trials. In February, an FDA Advisory Committee recommended that Qnexa be approved, and it is largely expected that the FDA will follow the committee’s recommendation (for more information, see new now next in diaTribe #40.) If approved, Qnexa will likely launch before Belviq, as it faces fewer regulatory obstacles with the DEA. After 13 years without any approvals for new obesity drugs (and even several obesity drug removals), things are looking up for patients and healthcare providers in search of alternative weight loss options. We hope that Belviq is just the first of several obesity drugs to receive approval in the coming years, and we are glad that obesity finally seems to be recognized as on par with other diseases, worthy and in great need of additional treatment options. –TT/BK
The development of a pen device for the once weekly GLP-1 agonist Bydureon (exenatide once-weekly) has hit a snag. Amylin (the drug’s manufacturer) had previously said that the pen would be available by late 2012 or early 2013. In a setback, however, the FDA has requested additional testing data, which is expected to delay the submission and approval of the pen until later next year. As a reminder, GLP-1 agonists are injectable type 2 diabetes drugs that stimulate the body to produce insulin and reduce glucose production only when blood glucose levels are too high. Because of these effects, GLP-1 agonists help improve blood glucose control without increasing the risk for hypoglycemia. GLP-1 agonists also suppress appetite, which can help people lose weight. Besides Bydureon, other currently available GLP-1 agonists include Victoza (Novo Nordisk’s liraglutide) and Byetta (Amylin’s exenatide). While these other drugs require more frequent shots than Bydureon (once a day with Victoza and twice a day with Byetta, compared to once a week with Bydureon), they both come in easy-to-use pen devices. Currently, Bydureon uses a system similar to a glucagon injection, which entails six steps to prepare and inject the drug (click here for a video demonstration). A Bydureon pen is expected to simplify its administration. Although exact details on the pen have not yet been released, injection will likely require three steps: 1) twist the device to combine the drug’s components; 2) shake the pen to mix the drug’s components; and 3) inject the drug. —BK
In June 2012, Medtronic held an Investor Conference to describe its upcoming products and expectations for the next five years. One of the biggest news items for patients was that the Medtronic Veo insulin pump, now called the MiniMed 530G in the US, has been submitted to FDA. This pump will have a low-glucose suspend feature and will also include the newer, more accurate Enlite CGM sensor (for reviews of the Enlite, see test drive in diaTribe #32 and thinking like a pancreas in diaTribe #36). We understand that early interaction with the FDA has been positive, and Medtronic hopes for approval in about a year (i.e., around June 2013). Encouragingly, this news represents a significant acceleration over the previous timeline for its FDA submission. It’s about time too, since the Medtronic Veo has been available outside the US since 2009! Additionally, we believe the positive regulatory news may allow Animas to move faster on the development of its Hypoglycemia-Hyperglycemia Minimizer System (see conference pearls in this issue for more information).
Also in the near term is the Medtronic MiniMed 640G, the second step in the path to an artificial pancreas. This new pump takes the low-glucose suspend feature in the Veo and the MiniMed 530G one step further – instead of suspending insulin delivery only when a hypoglycemic threshold is crossed, the upcoming MiniMed 640G will suspend insulin delivery when hypoglycemia is predicted (i.e., a hypoglycemia minimizer, or what Medtronic is calling “predictive low-glucose management”). The company plans to launch the pump early next year (2013) in Europe and in two to three years in the US. We were very encouraged to hear this news and believe the MiniMed 640G could further help patients reduce the frequency and duration of hypoglycemia, especially at night.
Longer-term, Medtronic has several other new diabetes technologies in the works. The company’s long-awaited patch pump is now in the final design and review phase and is expected to launch in the next two to three years (fingers crossed). A next-generation version of the Enlite CGM sensor is also slated to launch in that time frame. Even beyond that, Medtronic is working on an overnight closed-loop system that would essentially automate nocturnal blood glucose control and a CGM sensor that does not require fingersticks – exciting!
Medtronic also announced a partnership with JDRF and the Helmsley Charitable Trust. The three-year endeavor is focused on developing a new type of CGM sensor for use in the artificial pancreas (for more on the current status of the artificial pancreas, see conference pearls in diaTribe #40, learning curve in diaTribe #39, and conference pearls in diaTribe #38). Medtronic will seek to combine two different methods of measuring glucose, creating a so-called “redundant sensor” – in other words, current sensor technology (based on a chemical reaction using glucose oxidase) will be combined with a completely different, future sensor technology (based on fluorescence). The hope is that such a redundant approach will increase the accuracy, reliability, and safety of CGM readings, and thus improve the performance of an artificial pancreas. The partnership is one of the largest collaborations to date by JDRF and the commitments are up to $17 million in funding over three years. We also noticed a particularly high-level of excitement on the informative follow-up call announcing the news. To view the PowerPoint slides and listen to the call’s audio, please visit http://engage.vevent.com/rt/medtronic~060512, enter your email address on the bottom of the page to register, and then login on the left side of the page. –AB
In May, Johnson & Johnson submitted its SGLT-2 inhibitor canagliflozin for approval in the US. On average, the FDA takes about ten months to review applications for new drugs, placing a possible approval date in March 2013. If approved, canagliflozin would become the first SGLT-2 inhibitor to enter the US market. Canagliflozin was also submitted for approval in Europe on June 26, putting a potential approval sometime in the middle of 2013. As a reminder, SGLT-2 inhibitors are a class of type 2 diabetes drugs that cause users to excrete excess glucose through their urine (for more details, please see learning curve in diaTribe #24). At the American Diabetes Association (ADA) meeting this month, phase 3 trial results were reported for the first time for canagliflozin. In these trials, canagliflozin provided greater reductions in A1c than several other type 2 diabetes therapies, including the DPP-4 inhibitor Januvia (sitagliptin) and the sulfonylurea glimepiride. Canagliflozin also provided greater improvements in weight and blood pressure than either drug, with a low risk for hypoglycemia. As with other SGLT-2 inhibitors, however, canagliflozin was associated with higher rates of urinary tract infections and genital infections - although these side effects caused few participants to discontinue from the trial.
The SGLT-2 inhibitor dapagliflozin (Forxiga) was denied approval by the FDA in January. While Bristol-Myers Squibb and AstraZeneca (the manufacturers of dapagliflozin) have not discussed in depth the reasons behind the FDA’s rejection, the agency is likely concerned about potentially increased risk for bladder and breast cancer as well as liver damage detected in dapagliflozin’s clinical trials (for more information, please see new now next in diaTribe #39). Whether there is an actual increased risk for these side effects remains unclear, and the data reported thus far have not suggested any increased risk for cancer or liver injury with canagliflozin. Encouragingly, dapagliflozin was recommended for approval in Europe by an initial European regulatory assessment committee in April, and a final approval decision is expected from European regulatory authorities over the next several weeks (for more information, please see new now next in diaTribe #42). —AW/BK
In June, First Lady Michelle Obama and Walt Disney CEO Robert Iger announced a bold new plan to ban commercials and advertisements for unhealthy food products targeted at kids and families. Once it goes into effect in 2015, full meals that total more than 600 calories and food products high in added sugars and sodium will no longer be allowed to advertise on Disney’s various television channels, radio stations, and online. Yes! Disney hopes that the two-year delay (due to existing advertising contracts) will encourage companies to spend the intervening time improving the nutritional value of their products – we certainly hope so too, though we can also imagine companies tweaking products to just squeeze in under the new standards.
This isn’t the first aggressive step by Disney to be on the winning side in the fight against childhood obesity – it recently introduced Mickey Check, which places a logo of the world’s most beloved mouse on nutritious foods and menu items sold online and in the stores and restaurants of Disney’s US parks and resorts. The company has also announced plans to reduce sodium content by 25% in the over 12 million children’s meals sold annually in its theme parks. Finally, Disney will air public service announcements intended to help children see exercise and healthy eating as fun, essential activities.
In our view, the ban itself will force a departure in how the Big Food industry typically behaves; it has consistently lobbied hard against any federal efforts to curb unhealthy food advertising to children. There are, of course, some questions about the efficacy of the ban, both in its ability to actually change children’s eating habits and to prevent unhealthy foods from slipping through its guidelines. Some also question whether the guidelines go far enough – as dietitian Susan Levin told the Tampa Bay Times, junk food cereals like Lucky Charms and Count Chocula actually meet Disney’s currently announced guidelines. Nevertheless, we see the move as an encouraging first step, and we’re hopeful that Disney’s actions will spur other media companies to follow suit. –AW/AB
To mark the end of this month’s 72nd American Diabetes Association (ADA) Scientific Sessions in Philadelphia (see conference pearls in this issue), diaTribe editor in chief Kelly Close and Taking Control of Your Diabetes (TCOYD) founder and director Dr. Steven Edelman hosted the Sixth Annual Diabetes Forum. The lively panel discussion featured Drs. Julio Rosenstock (Dallas Diabetes & Endocrine Center, Dallas, TX); Lori Laffel (Joslin Diabetes Center, Boston, MA); James R. Gavin III (Emory University School of Medicine, Atlanta, GA); William Cefalu (Louisiana State University School of Medicine, New Orleans, LA); and Dr. John Buse (University of North Carolina School of Medicine, Chapel Hill, NC).
The panel reviewed the newly announced ADA/EASD position statement on the treatment of type 2 diabetes, which advocates for an individualized, patient-centered approach to therapy (see from the editor in diaTribe #43). Declaring this “a very rational approach,” Dr. Cefalu praised the statement for allowing the “physician to look at the patient and choose the medication that’s most appropriate at that time – I don’t think you can pencil a patient into a diagram.” Dr. Gavin called it “a more robust toolbox than the previous version.” But he also pointed out, “There’s little that you can do to hold the hands with PCPs to guide them through the decision process.” To this point, Kelly Close observed that primary care providers might find it hard to personalize and individualize therapy, given the wide array of choices.
Regarding the statement’s call for expanded patient involvement, Dr. Buse observed that in his practice, about 80% of patients do well, while 20% “have psychosocial problems” that present challenges. Dr. Laffel argued that “there’s no such thing as a bad patient – they’re fighting a bad disease.” While the panel was generally realistic about the challenges of actually implementing the recommendations of the position statement, they were in general agreement that this more patient-centered approach was the best way forward.
The results of the ORIGIN trial were also a major topic of the discussion (see conference pearls in this issue for more on its design and results ). Dr. Rosenstock was the most positive on the outcome, while most other panelists were far less enthusiastic. Overall, most felt ORIGIN was an interesting study but would not likely change the treatment of prediabetes or type 2 diabetes.
The evening closed with a discussion on the very real challenges of attracting the best and brightest to endocrinology, with Dr. Edelman declaring a “serious lack of young folks” in the field. The panel attributed this to the lack of time given to endocrinology in medical school – Dr. Rosenstock estimated only three hours are spent on the topic throughout all of medical school – as well as the lack of interest in clinical research, the rejection of grants, and the reduced earning potential for endocrinologists relative to other medical specialties. As the number of people with diabetes grows, we certainly hope this changes in the coming years. –AW
diaTribe salutes director Jennifer Mackenzie for her emerging film Sugar Babies. The documentary examines the impact of type 1 and type 2 diabetes on children in America. Visit the website and spread the word to help in their final 25 days of funding! Jennifer was the director of the renowned Kick Like a Girl and is clearly an incredible talent - watch a clip of Sugar Babies and let's help get the word out about this critical work.