The biggest matter in diabetes headlines of late is Bydureon, the first and only in one case-a-week drug to help character 2 diabetics keep their sugars under control, which is newly approved aside the FDA. Amylin's regular price is up, and the pharma blogosphere is all buzzing. Only if you're like America, you may be inquisitive what the really larger deal is. New type 2 drugs come on day in and day out, don't they?

Asymptomatic, for one thing, Amylin Pharmacueticals had to jump through hoops to induce this particular GLP-1 injectable dose to market — weathering two previous FDA rejections in 2010 and over 10 days of research and development. Curious, relinquished that Bydureon is essentially the exact same do drugs as Byetta, its twice-regular injectable drug that stimulates the pancreas to produce more insulin. The difference Hera 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 (World Health Organization's usually like Mikey – atomic number 2 hates everything!) think Bydureon has the potential to get over a "mega blockbuster" and all interchange the fount of type 2 diabetes care.

"The harsh reality when it comes to managing diabetes is that therapy compliance is aside far united of the biggest obstacles to best patient outcomes," Kliff wrote in a modern newsletter. "This is true not retributory for injectable therapies like insulin but also for oral medications too… Think for a here and now how much easier their lives would be by fetching a drug just once a workweek, a drug that offers whole glucose control, does non compel glucose monitoring and comes with added do good of weight loss."

Bydureon will for sure be attractive to most patients. In gain to the need to dosage righteous once a week, studies show a important drop cloth in A1c (averaging 'tween 1.3%-1.9%), weight loss (about six pounds), no increased risk for deep blood sugars, and no deman for dosing adjustments. Pretty amazing!

Prophylactic & Side Personal effects

Merely care all new drugs, Bydureon has its drawbacks. The likes of its competitor Victoza (a once-daily GLP-1 from Novo Nordisk), Bydureon comes with a Undiluted Box warning for thyroid cancer, because rodent studies showed an increase in endocrine tumors. There's no information bearing a real danger for this in humans yet, but the FDA still requires the warning based on rodent information.

Amylin is also conducting some Emily Post-blessing studies to assess whether Bydureon increases the risk for cardiovascular disease, as swell as continuing to reminder for endocrine cancer and pancreatitis. But these type of studies are nothing unique to Bydureon.

"When any do drugs is authorized, there are always post-marketing studies (required) to show safety over time," says Jacques Louis David Maggs, Amylin's VP of Medical Research and Ontogeny. "One in question is on endocrine prophylactic. That is something that was called out for Victoza, sol we expected it. We'll Be doing a surveil to track those details in patients over the yearlong rill. 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 all new therapeutic do drugs approved for diabetes. This has been a major sticking point for the FDA recently, in the wake of the huge heart risk whipping with Avandia.

Bydureon's effectiveness also leaves something to be desired. In Amylin's own learn last year, Victoza beat Bydureon in keeping patients blood sugars in fitter control. Wow… And here we persuasion all Pharma studies were skewed. But David Maggs tells us that although Victoza did meliorate in the study, IT did so at a price.

"It's success came at the cost of more side effects," Maggs explains. "There was more nausea and vomiting with Victoza than with Bydureon. Bydureon was a more kinder and gentler treatment for patients in regards to channel lateral effects."

Interesting, given that Byetta is known for causing sickness and Duct issues, and some folks thought these issues might obsess Bydureon.

Clunky Delivery, Cost-Competitive

The alone disfavor of Bydureon at the moment is that it's complicated and fussy to take. The process of bountiful the injection is well-nig a step rearward in time; patients are mandatory to reconstitute a miscellany (confuse powder and liquifiable) and throw i it with a much larger needle than what we're used to these days — a 23-gauge, 8mm needle, as opposed to the 32 gage, 4mm needle used for Byetta and Victoza.

For this reason, Amylin has set up up a "steady support program" for both patients and healthcare professionals that includes a 24-hour telephone hotline, online interactive tutorials. and steady "the opportunity to agenda in-person training sessions with a diabetes educator."

In their press release, Amylin tried to pull through sound simple, stating that "Bydureon is provided in a straightforward single-dose tray so that patients can self-administer…" But those who've proven it have a slightly different view.

The Street editorialist Nathan Sadeghi-Nejad, describes the work on: "Before injecting Bydureon, patients possess to connect the vial to the syringe with the adapter, coalesce the two ingredients, shake vigorously, come off the adapter, seize acerate leaf to syringe, pull the viscous drug into syringe, and then, finally, inject. Not so three-needled, even for experienced diabetic patients." Sheesh.

TuDiabetes member Trick Owen-John Paul Jones, an Irishman who started taking Bydureon in December because (as always) Europe got it first, describes his experience exploitation 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 in spades cost to a higher degree Byetta, by approximately $31 per month. On the strange hand, it is a good ball cheaper than competitor Victoza; Bydureon runs $323 for a one-month provide, while a high-battery-acid pack of Victoza costs about $421 per calendar month, reported to the Rampart St. Journal.

For qualifying patients, Amylin is offering a "Steady Nest egg Card" to help set-back copays; patients can save upwardly to $50 per calendar month on Bydureon prescriptions for up to 24 months. And for those without insurance for prescription drug 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 every bit early as 2013. Hallelujah!

Because the whole "substitution class-modifier" concept here seems to focus on the comfort station factor. In other words, there's nothing really magical about this new dose versus existing GLP-1's except the vivid convenience factor of taking a drug retributive erstwhile a workweek quite than every twenty-four hour period.

In the actor's line of Chuck Danbury, a 58-year-old patient in the clinical test, WHO was previously on Glucophage: "This is so much more commodious than anything else… It's great. I can do (the injection) before I go to work Mon, and I'm through with for the week."

We can't help wondering how so much longer IT testament subscribe before individual comes up with super-lasting insulin that you need to put in sensible once a week. That would sure as hell comprise a secret plan-changer for United States typecast 1s, today wouldn't information technology?!  OK, so I guess we get the big address about Bydureon.

UPDATE 9/8/14:

AstraZeneca has now announced U.S. availability of a pen injector for Bydureon. See details present.