Januvia is going to eat Byetta's lunch
Januvia hit our shelves this past week, and I marveled at how inexpensive it was for a brand new drug. (~$300, if dim memory serves.) I think Merck's going to have a runaway hit on their hands, and Amylin and Lilly are going to be the ones that lose out. I almost feel like I'm stating the obvious here — heck, maybe I am, I haven't kept with any business news and speculation in several months.
Exenatide (Byetta) is a glucagon-like peptide analog that responds to glucose by stimulating insulin release and inhibiting glucagon release. It also slows gastric emptying, inhibits synthesis of glucagon, and stimulates beta cell neogenesis by preventing beta cell death. It only responds in the presence of glucose, which means there's low risk for hypoglycemia.
Unfortunately, GLP-1 is broken down by DPP-IV, which limits native GLP-1 half-life to about 90 seconds. GLP-1 is also efficiently cleared by the kidneys. The other downside to Byetta is the fact that it's injected.
Sitagliptin (Januvia) prevents the breakdown of the body's own GLP-1 (and other incretin hormones) by inhibiting DPP-IV. As an oral tablet, patient compliance is likely to be higher, or at the very least, it's more convenient than poking oneself.
Despite having entirely different mechanisms of action, the net effect is the same: higher levels of GLP-1 in the body, with low risk of hypoglycemia. Both Byetta and Januvia are likely to help patients lose weight as well. There's been some talk about possibly getting Byetta approved as a weight-loss drug — I don't know how far along this idea is, however.
It's only a matter of time before we start getting insurance rejections for prior authorizations telling us that the doctor needs to try Januvia before they'll approve Byetta. This is good news for those seniors on Medicare Part D plans as well — Januvia can save them a pile of money because it's just so much cheaper than Byetta.
So to recap:
- Easier to store (no refrigeration)
- Oral tablet vs injection
- Once a day dosing instead of twice a day poking
- Cheaper
I think all the pieces are in place for Merck is going to eat Eli Lilly and Amylin's lunch here. It seems one investment house is also predicting something similar. (PDF)
[tags]Medicine, pharmacy, diabetes, byetta, januvia, sitagliptin, exenatide[/tags]
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That post sounds like from a Merck drug rep - Januvia does not work as well as Byetta and not even as good as metformin. It barely lowers hba1c to FDA rec. levels and has only weight neutral effect and that may be suspect as in the Merck clinical trials while Januvia caused no weight gain, 'placebo' pill had some weight loss, so I wonder if there was added exercise and diet in the clinical trials, possibly? Also, byetta lowers weight consistently and continually over time even up to 2 years and beyond as shown in clinical trials. It controls blood sugar comparable to lantus and mixed 70/30 insulins post prandial and has been shown in lab animals to promote beta cell regeneration. And while the drug is injectable, it is a relatively pain free 'pen needle' given twice daily, and for many requires less 'finger pricking' (which causes more pain) due to better blood sugar control. Also, the company Amylin has a long acting form (LAR Byetta) in late stage clinical trials for a once weekly dosage form which has been shown to work even better and less side effects than the twice daily form. It is not recommended for weight loss in non-diabetics, but their other drug approved Symlin(pramlintide) is in phase II clinical trials for weight loss for non-diabetics, and has been shown to be effective, and is presently approved for type I and II diabetics, and a side effect is weight loss for many. Talk to your doctor for his/her advice.
Comment by seemiketalk — November 15, 2006 @ 9:42 pm
You know, that's all well and good. I still like Byetta as a drug, but "better" is a highly subjective term. You're going to see insurance companies requiring doctors to try Januvia before reaching for the Byetta. I guarantee it. That alone will seriously hurt Amylin and be a boon for Merck.
Comment by RJS — November 15, 2006 @ 9:47 pm
tell me when I will 'see' those cheaper copays for Januvia - as I do want to learn. FYI, I am a pharmacist at a very large pharmacy, and so far, the lowest copay I have seen for Januvia, is within a few bucks from a hundred, and byetta is comparable to most older oral type II drugs and many blood pressure pills, around 30 dollars. You need to do your due diligence, as Januvia is not even top of line for oral treatmentfor T2s, metformin is first line. And just because a drug can be swallowed does not make it most efficacious, or even without side effects. Byetta is not only a better drug, it is a drug that most type II diabetics should at least try, especially if they are overweight and need better blood sugar control, before they end up in worse shape, in need of high insulin doses and then needing toe amputations and losing their vision, and MIs, which is what can happen with continual spikes in blood sugar and having higher than norm hba1c levels. Byetta may not work for everyone of course, and possibly Januvia will help there along with using metformin and possibly other orals and long acting insulin as well. No cure proven yet.
Comment by seemiketalk — November 15, 2006 @ 10:03 pm
Also, one of the best sites for good info on Byetta and the future of Amylin the company behind the drug can be found at http://www.investorvillage.com in which there are many health care professionals and scientist types as well as many that have used the drug. Also another good site is http://www.amylin.com
Comment by seemiketalk — November 15, 2006 @ 10:18 pm
You see to have a vendetta of some kind. I'm not really sure why. I've got nothing riding on the success of Byetta or Januvia. You say I read like a Press Release from Merck. I've got no connections to Merck. Nor do I have a vested interest in their financial success.
1) It's only a matter of time. Januvia is new. It's less expensive than its closest competition. By a lot.
2) Byetta will go Prior Authorization for a great many people, with Sitagliptin being the preferred drug to try first.
3) People like oral medications more than they like injecting themselves, as a rule.
4) It's a proven fact that once daily dosing leads to better patient compliance. This is a good thing. (Not that I think Byetta has a high rate of patient non-compliance.)
I never said it did. Nor did I imply it.
I am aware of what happens over time, thanks.
And "better" like I said, is entirely subjective. It's "better" from a therapeutic outcome point of view. Is it "better" for someone — like my dad — who pays for all of his medications out of pocket?
Probably not.
You don't say?
I am merely saying that Januvia's existence will hurt Amylin and Byetta from a financial point of view. Something you are apparently unwilling or unable to grasp.
Just watch. It will happen. I'd say within six months. If I'm wrong, I'll be the first to admit it.
Comment by RJS — November 15, 2006 @ 11:37 pm
How about an honest comparison between Byetta and Januvia. I was on Byetta and just switched to Januvia because it was in pill form. Should I have stayed on Byetta? Is one better than the other or are they about the same?
Comment by Gmac — November 18, 2006 @ 9:30 am
If you don't really know you will know soon enough; If Januvia is truly as 'equal' to byetta your blood sugar levels will stay the same or continue to improve and your weight would continue to fall and not gain, and you would continue to feel better and you would not feel like you have to eat a horse at each meal….and I could go on and on, but if you are truly on Januvia I would encourage you to do research on the web and if you are not seeing an endo who really knows the difference, I would encourage you to do so. I have already heard of a couple people that had switched to Januvia, and have already switched back to byetta. Also, what really causes you pain, the pen needle injection of the drug, or the needle pricks necessary for blood sugar tests (even if taking an oral drug)?
SMT
Comment by SMT — November 18, 2006 @ 10:12 am
BYETTA HAS ONE BIG DOWN FALL THOUGH. IT CAUSES NAUSEA IN MOST PEOPLE. I KNOW I TRIED SEVERAL TIMES TO TAKE IT AND I COULDN'T STAND HOW SICK I FELT ON IT. I EVEN VOMITED WITH IT. SO FAR DAY 2 , JANUVIA DROP MY SUGAR FROM 225 TO 189 IN THE AM READING. I'M STICKING WITH JANUVIA.
Comment by MARCIA — December 26, 2006 @ 6:52 am
Januvia has had dramatic results for me. I was taking Avandia, Glipizide, and Metformin with levels still over 200. Januvia (without the Glipizide) has consistently decreased my levels by 50 or more. My average fasting has come down to 120-150. Only problem I had was an interaction with Glipizide (caused rapid heart rate, shortness of breath, panic type symptoms) which I discontinued.
Comment by John — December 30, 2006 @ 12:44 am
Byetta is working along with 1000mg Metphormine and 4mg of Glimpride.I had the sick symptoms at 5mg but when I increased to 10mg they went away. I didn't experience weight loss on Byetta wish I did. My doctor says I am the opposite of most people. The shot doesn't bother me at all staying refridgerated does.
Comment by Dawn — January 14, 2007 @ 5:06 pm
I'm not convinced that Merck is going to eat Lilly's lunch as you claim; Lilly's biggest problem in its diabetes business is in a segment the company has long taken for granted: insulin. The company has seen its market share plunge from 82% in 2000 to 43% in 2006 according to data from IMS Health. The market for insulin is mainly patients with type 1 diabetes, a market that has no other therapeutic options. Januvia is irrelevant for that market, and the competitors aren't Merck, their Novo Nordisk and Sanofi Aventis.
Comment by Scott — February 13, 2007 @ 3:57 pm
I was taking Metforin and my sugar level had been well controlled. Recently it went up to almost 300 and my doctor changed my Rx to Januvia. I have been taking 100 mg each day for over two weeks with not improvement. The only recent meds change was prescription fish oil which should not have affected my sugar level. Comments?
Comment by Robert Wright — April 26, 2007 @ 6:20 pm
Generally speaking, one maxes out the biguanide before adding another drug. (Typically you don't replace metformin with another drug, you simply add to the metformin regimen.)
But diabetes is a tricky disease, so I'm not really sure.
And the fish oil is fine.
Comment by RJS — April 27, 2007 @ 7:29 am
I have used Byetta to great results both in sugar control and weight loss ( about 18 #)
the nausa that came at all unexpected times and almost total loss of bowel control prompted me to go back to glucatrol. athe weight did come back slowly 9partly my fault). I am now working to get to Merck's Januvia, as a retiree of merck I can get their medications free, this is also a consideration. not a primary one at present.
Byetta's injection sachedule seems to alyays be in conflict with trying to keep up with life's demands, the storage of pens in cold and having somewhere to keep them when travel is requires light baggage. The nausa that creeps up and bites one at unexpected times is often a pain. The people I've spoken to that were using Byetta seem to have most of the same side effects, some less some worse.
Comment by William G Rodgers — June 24, 2007 @ 10:53 pm
Byetta - no nausea, BG down below 110 from spikes as high as 300. Some sinus aches at times but nothing of consequence or lasting.
Comment by Jim Stewart — July 27, 2007 @ 2:43 pm
I would like to know if Januvia 1/2 tablet with Byetta would help me. I was told to stop Actos 45 because of joint pain and will try Januvia with the Byetta. I feel like Byetta is a good thing I have lost a little weight not much. Any major side effects that you know of?
yolanda
Comment by Yolanda — September 4, 2007 @ 5:24 pm
I have just started taking Januvia samples 8 days ago and I have seen amazing results. My morning numbers have gone from around 138 to around 115 or less. My between meals numbers are now under 95, sometimes in the high 80s. And my 2 hour post meal numbers have been incredible - mostly around 115 or less even after eating (for testing purposes only) pizza, pasta, french toast and raspberry cheese cake. I haven't tried Byetta, but I can say that Januvia has been great so far. My main worry now is getting my insurance company to approve it, but with these numbers I will fight them tooth and nail if they don't.
Comment by Claude — September 23, 2007 @ 4:52 pm
They're slowly coming around — insurers are realizing that it's (WAY) cheaper than Byetta, so more of them are getting on the bandwagon.
This might sound strange, but for a relatively new drug, Januvia isn't particularly expensive, even when your insurer doesn't cover it.
Comment by RJS — September 23, 2007 @ 4:56 pm
I had horrible uncontrolled diabetes on metformin and glipizide alone. I was either too high or too low all the time and felt really bad. I was also wanting to eat everything in sight!
The byetta really changed my life. In 3 months my A1C went from 9.3 to 6.7 and I lost 20 pounds. I had nausea and heartburn really bad with the byetta both when I started the 5mcg and then 10. My endocrinologist had me take 150mg per day of zantac (available over the counter but check for drug interactions with your pharmacist before taking it) and it stopped the severe indigestion and nausea. Eventually I was able to stop taking the zantac altogether as my body adjusted to the byetta. If you can hang in there long enough, the symptoms go away with time. I currently take metformin, glipizide and byetta, but the glipizide is now the lowest dose you can take- half of a 5mg tablet twice a day. I was on a much higher dose before.
Comment by Chris — December 9, 2007 @ 5:37 pm
Some folks being put in Byetta along with Metformin deal with PCOS (Polycystic Overian Syndrome)- insulin resistance and are not considered to be diabetic. I am one of these persons who has PCOS, Hypothyroidism and is overweight. I have not filled my Byetta script even though I have been told I would only pay 25.00 a month (not including the needles). I have held off on filling it because I had heard about Januvia. I really do not want to be dealing with an injection if Januvia will give me the same results. FYI, Byetta no longer has to be kept cold from what I have been told. Anyway, is there anyone else out there (those of you posting) who is dealing with PCOS, hypothyroidism and is not diabetic?
Comment by Caryn D. — July 14, 2008 @ 2:11 pm