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On July 17, the FDA approved Vivus’ weight-loss medication Qsymia (formerly called Qnexa), just several weeks after the approval of Arena’s Belviq (see new now next in diaTribe #44). Qsymia is a once daily pill intended for use with diet and exercise by 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 (e.g., diabetes, high blood pressure, high cholesterol). Qsymia should be available in late 2012, though initially only through certified mail-order pharmacies. Vivus has not yet disclosed how much Qsymia will cost; regardless, most people who take the drug will likely need to pay for it out of pocket when it’s launched. Insurance coverage for obesity medications has historically been limited, though Vivus is optimistic it will obtain coverage within a year of launching Qsymia because the drug has been shown to reduce weight-related health problems.
In clinical trials, Qsymia treatment brought about an average ~10% weight loss over two years, compared to ~2% weight loss with placebo. The most common side effects include paresthesia (“pins and needles”), dry mouth, and constipation. The label for Qsymia recommends starting at a low dose and slowly increasing the dose over time, presumably to minimize side effects and to help patients tolerate the drug. Importantly, the drug’s label includes stopping rules (instructions to discontinue if a pre-specified amount of weight loss is not achieved by a certain time) to ensure that patients who are not responsive to the therapy are not needlessly exposed to its potential risks.
As background, in October 2010, the FDA chose not to approve the drug due in large part to the potential birth defect risk of topiramate, a component of the drug. Though in subsequent studies the drug had a lower birth defect rate than initially believed, infants exposed to the drug in the first trimester of pregnancy were found to be at higher risk for developing oral clefts. In this more recent approval cycle, Vivus developed a plan (called a Risk Evaluation and Mitigation Strategy or “REMS”) to minimize the use of Qsymia by pregnant women and thereby mitigate the risk of birth defects. The REMS for Qsymia includes educational materials for patients and healthcare professionals on the risk of birth defects, the importance of contraception and regular pregnancy testing for women using Qsymia, and the need to stop taking Qsymia immediately if and when one gets pregnant. The FDA’s approval of Qsymia reflects the Agency’s high level of comfort that the REMS can effectively minimize use of the drug by pregnant women.
After so long without any new medications for the treatment of obesity, two new options will become available in the not-too-distant future – Qsymia and Belviq. Encouragingly, obesity is becoming increasingly recognized as a chronic disease with significant health consequences if left unaddressed, as opposed to a cosmetic condition resulting from lack of willpower and self-control – or even worse, a personal choice. In the coming months and years, we hope to see additional obesity treatments – lifestyle interventions, drugs, devices, online counseling, and combinations of all of them – become available, as well as additional efforts to prevent obesity from developing in the first place. –JD/VW
In June, pharmaceutical giant Bristol-Myers Squibb (BMS) and its partner AstraZeneca (AZ) acquired the important biotech company Amylin for a cool $7 billion, which we believe will be good news for people with diabetes. Amylin manufactures two of the three currently available GLP-1 agonists – the twice-daily Byetta (exenatide) and the once-weekly Bydureon (exenatide once weekly) – as well as the type 1 and type 2 diabetes therapy Symlin (pramlintide). Besides these products, Amylin is developing a pen device for Bydureon that is expected to be easier to administer than the current version (approval expected in 2013), a once-monthly GLP-1 agonist (exenatide once-monthly) expected to enter phase 3 studies next year, and a new “dual-peptide” therapy for type 2 diabetes that remains in initial trials. The once-monthly is the part of Amylin that struck us as truly exceptional, although GLP-1, the main focus of the company, has also clearly begun to transform diabetes treatment for type 2 (and perhaps type 1, as we noted in our test drive in diaTribe #26).
Through their acquisition of Amylin, BMS and AZ will substantially strengthen their product offerings for type 2 patients. The companies already have one DPP-4 inhibitor on the market Onglyza (saxagliptin) and are trying to secure FDA approval for their SGLT-2 inhibitor, dapagliflozin. Now with Byetta and Bydureon, BMS and AZ become the only companies with approved products in two (and eventually perhaps all three) of the new major drug classes (GLP-1 agonists, DPP-4 inhibitors, and SGLT-2 inhibitors), providing more options to patients with varying treatment needs. The opportunity to provide a variety of treatments (either alone or in combination) will be especially important as doctors continue to focus more on personalized treatment regimens for each patient based on his or her medical profile, history of diabetes, and lifestyle – a strategy that was recently supported in a position statement from the American Diabetes Association and European Association for the Study of Diabetes.
With substantially more financial resources than Amylin, we hope to see BMS and AZ work to continually expand access to GLP-1 agonists to more patients and providers as well as speed improvements in this exciting drug class in the coming years. We expect that BMS/AZ/Amylin’s combined sales forces will be capable of educating even more healthcare providers about the benefits of GLP-1 agonists (strong improvements in blood glucose, weight loss, low risk for hypoglycemia, possible protective effects on the cardiovascular system) – AZ, especially, has significant experience with primary care providers. In the coming weeks, we hope to hear more about BMS and AZ’s plans for Amylin’s products as the companies provide updates about their overall business strategies. We’ll keep you posted! –NR/EC/BK
On July 13, Johnson & Johnson acquired Calibra Medical, maker of the Finesse “insulin patch-pen” for type 1 and type 2 diabetes. The slimly designed Finesse (2 inches long, 1 inch wide, and only 1⁄4 inch thick) is worn on the body, is entirely mechanical (i.e., no handheld controller, displays, or batteries), and is designed to deliver bolus doses of rapid-acting insulin by simultaneously pressing two buttons on the device. A preset dose of one or two units of bolus insulin can be administered per click, and if more insulin is needed than the preset dose, the buttons can be pushed repeatedly. The device does not deliver basal insulin or a basal rate, so patients using it take their basal insulin separately – this allows the device to be far smaller than a typical pump, although it is obviously not as physiologic. The Finesse has a total reservoir capacity of 200 units, meaning the Finesse “patch-pen” will last at least three days for the typical user. (Editor’s Note: This information is based on published product information prior to the acquisition, so it may change).
In our view, the biggest benefits of the Calibra system are simplicity, size, and discretion (e.g., ability to quickly bolus through clothing). Compared to syringes or pens, we think the Finesse will offer a very useful alternative for people with type 2 diabetes who currently take (or should be taking) mealtime insulin. Additionally, we believe some people with type 1 diabetes may be attracted to Calibra’s device as well – while they would still need to take basal insulin using an insulin pen or syringe, the Finesse should make taking mealtime insulin much less of a hassle and much more private. In the future, we also believe the device could be used not only for just insulin, but potentially for Symlin, GLP-1, and other hormones in development.
We think this acquisition represents exciting news for patients, as the strong resources and expertise of Johnson & Johnson should help bring the Finesse to market in a big way. There is no timeline yet on when the device might be available to patients, though we note that FDA first approved it in 2010 (see new now next in diaTribe #20). We very much look forward to test-driving it once it becomes available. –AB
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 few weeks of funding! Jenny 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.
As far as we know, there has never been a documentary on diabetes. Jenny is now filling that void. Much has been said and written about children with diabetes, both type 1 and type 2. What makes Sugar Babies special is the kids themselves tell their own stories, and viewers will gain a much deeper understanding of all the complexities – the triumphs, the pressures, and the burdens – of living with this disease for the children and their families.
Viewers will meet Caidence, a precious 3-year-old whose parents find themselves overwhelmed by the financial demands of their daughter’s disease; and Prince, a charismatic teenager from Brooklyn who must overcome diabetes burnout. They will meet Ann Marie, the mother of a type 1 boy who rallies her community after an alarming surge in diagnoses; and Morgan and Ronnie, young teenage siblings who must completely change their lifestyle after being diagnosed with type 2 diabetes.
As the mother of a type 1 daughter, Jenny is well qualified to tell this story. She has spent countless hours researching, interviewing, and editing her film, and we’re excited that she is close to bringing it to a much wider audience. We encourage you to spread the word about what is sure to be an absolutely remarkable film.
They say that bad things come in threes. This certainly held true for up-and-coming obesity medications in late 2010 and early 2011, when Arena’s Belviq (formerly called Lorqess), Vivus’ Qsymia (formerly called Qnexa), and Orexigen’s Contrave were all denied FDA approval due to unresolved safety concerns. What people fail to mention is that there is often a silver lining – recently, Belviq and Qsymia gained FDA approval, and Orexigen announced that Contrave is progressing faster than expected on its path to resubmission.
In Contrave’s case, the FDA denied approval of the drug in early 2011 due to the slight increases in heart rate and blood pressure observed with Contrave treatment in clinical trials (see new now next in diaTribe #30). Concerned with the drug’s cardiovascular safety, the FDA requested Orexigen to conduct an “outcomes trial” that would track cardiovascular “events” (e.g., stroke, heart attack, death attributable to cardiovascular causes). However, the agency’s initial request was too burdensome (in terms of trial size and duration), so Orexigen decided to halt the development of Contrave (see new now next in diaTribe #34). Following a series of interactions between Orexigen and the FDA, the agency clarified a feasible path forward to approval, easing the criteria for the outcomes study and allowing Orexigen to use interim results from the trial as the basis for approval (see new now next in diaTribe #36).
The cardiovascular outcomes trial for Contrave, dubbed the Light Study, began enrolling participants in early June 2012. Orexigen recently announced that enrollment for the trial is going faster than expected (over 1,500 participants enrolled in the first five-and-a-half weeks alone!). With speedy enrollment, there is the possibility (but not a guarantee) that Orexigen will be able to resubmit Contrave to the FDA for review sooner than originally anticipated (early 2014). This is because the outcomes trial is “event-driven,” meaning that participants in the trial have to experience a pre-specified number of events before the interim analysis (and resubmission) can take place. If Contrave is shown to be safe in terms of its cardiovascular risk, hopefully it won’t be too long before the drug joins Belviq and Qsymia on the market – the more safe and effective options for obesity, the better, since not all individuals will respond to any given therapy. –TT/VW
This month, the American Journal of Preventive Medicine (AJPM) and the Robert Wood Johnson Foundation announced the start of The Childhood Obesity Challenge, a competition to find new, creative ways to combat childhood obesity. The contest is encouraging anyone and everyone to innovate and submit an idea to http://ajpmchallenge.calit2.net by the deadline of 5 PM EST on August 15, 2012. Both individuals and groups can enter and ideas can address any area in obesity. Examples include ways to keep children more active and better tools to measure how much children exercise each day. Submissions should include a short description of the idea and can be supplemented with videos, pictures, apps, or other media. The winning proposal will be featured in AJPM and receive $2,500, with the second place winner receiving $1,000 and third place $500. Even if you don’t enter the competition, check back on September 30 at ajpmchallenge.calit2.net/submissions to vote for your favorite proposal (and maybe leave with a new idea or two about keeping your community healthy) – the entry with the most votes will take home the Popular Choice Award and $1,000. –KM
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