The biggest thing in diabetes headlines of late is Bydureon, the first and only once-a-week drug to help type 2 diabetics keep their sugars in check, which is newly approved by the FDA. Amylin's stock price is up, and the pharma blogosphere is all abuzz. But if you're like us, you may be wondering what the really big deal is. New type 2 drugs come out all the time, don't they?
Well, for one thing, Amylin Pharmacueticals had to jump through hoops to get this particular GLP-1 injectable drug to market — weathering two previous FDA rejections in 2010 and over 10 years of research and development. Curious, given that Bydureon is essentially the exact same drug as Byetta, its twice-daily injectable drug that stimulates the pancreas to produce more insulin. The difference here is that the core ingredients have been mixed with another compound to extend the effects for an entire week. Because it's taken only once a week, experts like David Kliff of Diabetic Investor (who's usually like Mikey - he hates everything!) think Bydureon has the potential to become a "mega blockbuster" and completely change the face of type 2 diabetes care.
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"The harsh reality when it comes to managing diabetes is that therapy compliance is by far one of the biggest obstacles to better patient outcomes," Kliff wrote in a recent newsletter. "This is true not just for injectable therapies like insulin but also for oral medications too... Think for a moment how much easier their lives would be by taking a drug just once a week, a drug that offers solid glucose control, does not require glucose monitoring and comes with added benefit of weight loss."
Bydureon will certainly be attractive to most patients. In addition to the need to dose just once a week, studies show a significant drop in A1c (averaging between 1.3%-1.9%), weight loss (about six pounds), no increased risk for low blood sugars, and no need for dosing adjustments. Pretty impressive!
Safety & Side Effects
But like all new drugs, Bydureon has its drawbacks. Like its competitor Victoza (a once-daily GLP-1 from Novo Nordisk), Bydureon comes with a Black Box warning for thyroid cancer, because rodent studies showed an increase in thyroid tumors. There's no data supporting a real risk for this in humans yet, but the FDA still requires the warning based on rodent data.
Amylin is also conducting some post-approval studies to assess whether Bydureon increases the risk for cardiovascular disease, as well as continuing to monitor for thyroid cancer and pancreatitis. But these type of studies are nothing unique to Bydureon.
"When any drug is approved, there are always post-marketing studies (required) to show safety over time," says David Maggs, Amylin's VP of Medical Research and Development. "One in question is on thyroid safety. That is something that was called out for Victoza, so we expected it. We'll be doing a survey to track those details in patients over the long run. It's a very rare tumor and we don't believe this will be a significant concern."
Cardiovascular studies are now something that is required of every new therapeutic drug approved for diabetes. This has been a major sticking point for the FDA recently, in the wake of the huge heart risk debacle with Avandia.
Bydureon's effectiveness also leaves something to be desired. In Amylin's own study last year, Victoza beat Bydureon in keeping patients blood sugars in better control. Wow... And here we thought all Pharma studies were skewed. But David Maggs tells us that although Victoza did better in the study, it did so at a price.
"It's success came at the price of more side effects," Maggs explains. "There was more nausea and vomiting with Victoza than with Bydureon. Bydureon was a much kinder and gentler treatment for patients in regards to gastrointestinal side effects."
Interesting, given that Byetta is known for causing nausea and GI issues, and some folks thought these issues might haunt Bydureon.
Clunky Delivery, Cost-Competitive
The unique disadvantage of Bydureon at the moment is that it's complicated and fussy to take. The process of giving the injection is almost a step backwards in time; patients are required to reconstitute a mixture (mix up powder and liquid) and inject it with a much larger needle than what we're used to these days — a 23-gauge, 8mm needle, as opposed to the 32 gauge, 4mm needle used for Byetta and Victoza.
For this reason, Amylin has set up a "steady support program" for both patients and healthcare professionals that includes a 24-hour telephone hotline, online interactive tutorials. and even "the opportunity to schedule in-person training sessions with a diabetes educator."
In their press release, Amylin tried to make it sound simple, stating that "Bydureon is provided in a straightforward single-dose tray so that patients can self-administer..." But those who've tried it have a slightly different view.
The Street columnist Nathan Sadeghi-Nejad, describes the process: "Before injecting Bydureon, patients have to connect the vial to the syringe with the adapter, mix the two ingredients, shake vigorously, detach the adapter, attach needle to syringe, pull the viscous drug into syringe, and then, finally, inject. Not so simple, even for experienced diabetic patients." Sheesh.
TuDiabetes member John Owen-Jones, an Irishman who started taking Bydureon in December because (as always) Europe got it first, describes his experience using Bydureon: "The injection is a bit complicated as its a powder which needs to be mixed with a solvent in a syringe. The needles a little bit bigger than the one with the Byetta pen but still easy enough to inject."
The other bit of bad news for patients paying out of pocket is that Bydureon will definitely cost more than Byetta, by about $31 per month. On the other hand, it is a good chunk cheaper than competitor Victoza; Bydureon runs $323 for a one-month supply, while a high-dose pack of Victoza costs about $421 per month, according to the Wall St. Journal.
For qualifying patients, Amylin is offering a "Steady Savings Card" to help offset copays; patients can save up to $50 per month on Bydureon prescriptions for up to 24 months. And for those without insurance for prescription drugs, they've got a patient assistance program going as well.
Convenience is King
One thing to note: diaTribe reports that a pen injector for Bydureon is in the works and could be expected as early as 2013. Hallelujah!
Because the whole "paradigm-changer" concept here seems to focus on the convenience factor. In other words, there's nothing really magical about this new drug versus existing GLP-1's except the pure convenience factor of taking a drug just once a week rather than every day.
In the words of Chuck Danbury, a 58-year-old patient in the clinical trial, who was previously on Metformin: "This is so much more convenient than anything else... It's great. I can do (the injection) before I go to work Monday, and I'm done for the week."
We can't help wondering how much longer it will take before someone comes up with super-long-lasting insulin that you need to inject just once a week. That would sure as hell be a game-changer for us type 1s, now wouldn't it?! OK, so I guess we get the big deal about Bydureon.
AstraZeneca has now announced U.S. availability of a pen injector for Bydureon. See details here.