New Diabetes Drug Approved by the FDA
A new oral medication called Januvia (sitagliptin phosphate) has been approved by the FDA for management of Type 2 diabetes. It's the first in a new class of drugs called DPP-4 inhibitors. Januvia lowers blood sugar levels by blocking the enzyme known as dipeptidyl peptidase IV or DPP-4.
DPP-4 is responsible for breaking down the proteins that stimulate the insulin producing cells after a meal. If DPP-4 is inhibited, then the proteins can activate the release of insulin for a longer period of time, thereby lowering the glucose level in the blood.
Januvia showed good results in recent trials both in combination with other drugs, like metformin, and also by itself. It is prescribed for Type 2 diabetes only. For some people, diet, exercise and conventional medications are not enough to keep blood glucose levels in a good range. Januvia has been successful in clinical trials at helping to lower them when traditional methods aren't enough.
It cannot work with Type 1 because most of the funtioning insulin producing cells in the pancreas have been destroyed. It also has not been tested on Type 2 patients under 18 years of age.
Because Januvia works on prolonging the stimulation of insulin production, the risk of hypoglycemia is unlikely. Also there is little risk of weight gain. The most commonly reported side effects include upper respiratory infection, sore throat and/or headache.
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"For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels."
Januvia will be prescribed in a dose of 100 mg. once a day. If the patient is compromised by severe renal insufficiency, the dosage may be adjusted to 50 mg. per day. Merck & Co., Inc., the company who manufactures Januvia has set the price of Januvia at $4.86 per 100 mg. tablet. This works out to a little less than $150.00 a month. Januvia should be available at pharmacies soon. Diabetes patients who might be prescribed Januvia should check with their health insurance plan to see what the coverage will be.
Comments
When is this drug going to be available? I am in need of it badly as my diabetes levels are very high regardless of my attempts to exercise and control my sugar intake. I also try to eat healthy.
Hi,
According to the press release by Merck @ Co., Inc. (the company that manufactures Januvia) the medication should be in pharmacies “in the near future”. Check with your doctor to see if this is a good drug for you.
Price seems excessive on its face. Are insurance plans (mine is Aetna) ok with covering this?
i guess 4.86 per pill does not sound high to some, but to thos who have no prescription insurance, it would be impossible to afford. So it is only for the rich and a select group of people
At this time, that’s probably true that only people who can afford it or have insurance will be able to benefit. But, companies can only hold the patent on a drug for a certain number of years and after that it can be manufactured as a generic by more than one company. Then the price goes down due to the generic status and competition from other companies.
Is the drug exportedor sceduled to be exported to Australia in the near future?
Will the drug be exported to Australia, any news about this?
Hi,
I haven’t been able to locate information on whether Januvia has been approved in Australia. Your best bet might be calling your pharmacy or your doctor and asking them if they have any information on that.
Deb Manzella
I am taking Januvia in addition to Actos Plus which includes metformin. I have had good luck so far, but have experienced a headache which is a known side affect. I have also experienced a decrease in appetite which is good. I just have to make sure I do do according to my plan. Right now, my Medicare prescription plan won’t pay for it and my doctor is appealing the decision. I have been getting the samples from my doctor and have also used a month’s supply that the manufacturer supplied. Maybe I am a guniea pig of sorts. But I do believe I have had better glucose control. I will know when I get my next A1C taken next month. I test once a day and they have been very consistent. I have an odd symptom of diabetes where my glucose reading has been high in the mornings despite what I have eaten. This still happens despite the addition of Januvia. What I have been doing is eating a teaspoon of peanut butter before I go tobed and it seems to help. I found this suggestion on the Internet.
I am just starting to use this drug. My insurance may not cover it and I know they will not cover Byetta – What other alternatives other than metformin and glucatrol are out there.. Why are insurance companies so reluctant to cover new medications? I get so frustrated. My blood sugar is not in control with conventional pill type medication, don’t the insurance companies know that if they keep us diabetics healthy it will be cheaper for them in the long run?