Once-Weekly Type 2 Medicine Approved

On January 27, the US Food and Drug Administration (FDA) approved the Type 2 diabetes medicine exenatide extended-release for injectable suspension (brand name Bydureon), manufactured by Amylin Pharmaceuticals. Bydureon is a member of the class of drugs known as glucagon-like peptide-1 (GLP-1) receptor agonists. (Exenatide [Byetta] and liraglutide [Victoza] are the other members of this drug class.)

GLP-1 agonists work by stimulating the insulin-producing beta cells of the pancreas to release insulin in response to high blood glucose levels. Because of their glucose-dependant mechanism of action, drugs of this class are associated with a low rate of hypoglycemia (low blood glucose).

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Bydureon is an injected drug that is approved for use in conjunction with diet and exercise in people with Type 2 diabetes. Unlike all other diabetes medicines to date, Bydureon needs to be administered only once a week. The 2-milligram dose — which is packaged in a single-dose tray containing the medicine vial, vial connector, syringe, and needles (one as a spare) — can be injected at any time on the dosing day, with or without food. It should be administered under the skin in the abdomen, thigh, or upper arm.

The medicine, which is a modified version of the twice-daily injectable drug Byetta, was associated with a 1.6% reduction in A1C (an indicator of blood glucose control over the previous 2–3 months) over the course of a 24-week study, compared to a 0.9% A1C reduction in people taking Byetta. Those taking Bydureon also experienced an average weight loss of 5.1 pounds.

Bydureon was ultimately approved on its third attempt after a lengthy review process by the FDA to alleviate safety concerns. The label carries a warning stating that the medicine caused certain types of thyroid tumors in studies with rats, but that it is not known whether it causes such tumors in humans. Bydureon should not be used in people with a personal or family history of medullary thyroid cancer. The manufacturer will be assessing the impact of the medicine on both medullary thyroid cancer and cardiovascular events. Exenatide, the active ingredient in Bydureon, has also been associated with pancreatitis (inflammation of the pancreas), and people who are using this medicine should be evaluated for signs of this condition, including persistent, severe abdominal pain.

This medicine has not been studied in combination with insulin and should not be used to treat Type 1 diabetes or diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body).

The most common side effects in people using Bydureon are nausea, diarrhea, headache, vomiting, constipation, itching at injection site, nodules (small bumps) at the injection site, and indigestion. Although nausea is common when starting on the medicine, it may decrease over time.

Bydureon is expected to be available in pharmacies this month.

For more information, see the press release on the Eli Lilly Web site or see Bydureon’s Web site.

  • Steve Parker, M.D.

    FYI, the New York Times reported that the expected retail price will be $4,200 a year.

    -Steve

  • Suzanne

    Wow! That would be over $80 a week! I did get better results with Byetta other than Victoza but the twice daily before I ate was hard to remember!

  • leticia z. holmes

    my question is, this medicine is cover by blue cross?, and do I need to take any thing else?
    thank you.

  • Jade

    Ilive in Mexico now, and wonder if this drug will be available here under the same or another name.

  • Fran

    I did a two year clinical trial for Bydureon. I had minimal side effects, mainly some gas and occasionally astomach ache, but not very often. When it was delayed from being approved last year in March, I had to go on twice daily Byetta. It was much less effective in keeping my blood sugars stable. On once weekly Bydureon my morning blood sugrs were consistently around 85. My A1c was 5.7. This past year on twice daily Byetta I have struggled to keep it to 97 in the mornings and my A1c at 6.5. Byetta cost me $400 monthly through my HMO. I started ordering it from Canada for half of that. I regained nearly all the 60 pounds that I had lost on Bydureon this past year while taking Byetta instead. I plan to resart taking Bydureon once weekly as soon as it is available. I also plan to see if the manufacturer has a plan to help patients with the cost.

  • Jerry Anderson

    Whoa, this sounds good. I’m 82 years old and have
    had type 2 for 14 years. I’m hoping the cost will
    be paid by Medicare and Blue Cross. I presently
    take three oral medicines, this would be a welcome
    relief.

  • Ange Taylor

    Wow..really expensive medication to use! In order for most folks to probably get this medication covered by insurance they are probably going to have to have their physician write up a TAR, TREATMENT AUTHORIZATION REQUEST, and what most TARs require is that the patient has used other medications prior to this for that particular condition and that the patient had a particular adverse reaction or the medication is not at all working! For individuals on Medicare or Medi-Caid, this really might not be for them! When the company no longer has the patent on the medication, it will probably go way down but new meds always cost a lot!

  • Pam Schmidt

    I wonder if this new drug will be covered by health insurance or Medicare. I’m on Medicare, but have Group Health as my supplementary insurance which covers my prescriptions. Guess it’s a wait and see thing.

  • Nancy

    I am on the Lantus pen once before going to bed and i am taking 95 units which means I have to stick myself twice to take it all.Problem is,my blood sugar is still so sporatic it’s really uncontrollable.And the biggest problem is,I lost my two jobs and my home and my car.what that has to do with this is when I worked at a hosp.full time I had insurence.I lost that along with everything else.I get treated through the clinic but I am now diable and I can’t get medicare for two years.and they turned me down for medicade becouse I started getting disability checks.How could I gewt help?????

  • Lori

    sorry to be a fly in the ointment, but I just started Bydureon. I lost 15 pounds in three weeks, which is great. But then I found out that the pharmacy undercharged me for my first month’s dosage (4 shots). They charged me the price of only ONE shot. My insurance company (BCBS), BTW, will pick up NONE of the cost. I did a little research. Found prices ranging from $358 to $429 per MONTH. And this is out of pocket. And since my pockets haven’t been employed in a year and a half, I won’t be able to afford this drug any longer.

  • Dan schumacher

    Sorry folks don t know how anyone can afford these new drugs. My wife’s Doc set her up to use Victoza. And we didn’t find out what the cost was going to be till we went down and picked up the new prescription. It was going to cost her 250+ per month. The Doc did mention that some of the insurance co would not cover it. By the time the costs go down she will be on insulin.

  • Angela O

    I just took a new prescription for this medication to be filled. With BCBS, my copay is $178 a month. That is too much. Byetta costs me $50 a month.

  • Diane

    If it works so well for patients, why do they make it unaffordable for them. I can’t understand!
    Pharmaceutical companies always come out ahead and customers pay the piper. My husband was just prescribe this med and he is a veteran and the VA does not covers new medication. They are way behind on medication and prescribe only generics. We have been getting prices in MI and anywhere from, $370 to $450.00 per month. RIDICULOUS !!!!

  • nicky

    I have just been put on the bydueron once a week shot and before insurance covers it it cosys 464.00 a month my co pay is 87.20 im wondering if the twice a day shot is more cost effi ient they told me the one im on now helps with weight loss anuone got any suggestions

  • Jim

    I understand your plight Diane.if you were a lazy type ssi individual,you would get everything free. But because your not,we just have to put up with it.when I say lazy ssi, I mean only those whom abuse the system.we all have seen them.you know the ones that keep popped kids out to get more of our money.and our so called politicians allow it to happen.they get all their meds free,glasses gastric bypasses,dental,the whole Bango.i guess we have to pay more for our meds so they can get theirs free.sound like Obama, no care.