Print | Email | Share | Comments (1)

FDA Poised to Review Two New Drugs for Type 2 Diabetes

Mar 24, 2009

The FDA’s desire to scrutinize saxagliptin and liraglutide comes from its December 2008 directive calling for all new diabetes drug treatments to demonstrate that they do not increase cardiovascular risks.

The FDA has announced that starting in early April, its Endocrinologic and Metabolic Drugs Advisory Committee will begin looking into two new drugs for type 2 diabetes: saxagliptin tablets from Bristol-Meyers Squibb and liraglutide, an injection drug from Novo Nordisk.

Both drugs are designed to lower blood glucose levels in people with type 2 diabetes, but there are concerns that they may be linked to a higher occurrence of cardiovascular problems in diabetes patients. Consequently, the committee will focus on whether either treatment increases patients' risk of heart attacks or strokes.

Neither drug is a totally new therapy. Saxagliptin is similar to Merck's Januvia, a DPP-4 inhibitor that works by increasing the body's level of incretin hormones, which lowers blood glucose.

Liraglutide, like Amylin Pharmaceuticals' and Eli Lilly & Co.'s Byetta, is a long-acting form of the hormone GLP-1, which triggers the release of insulin. Unlike Byetta, which is injected twice daily, liraglutide will be marketed as a once-daily injection.

(Amylin and Lilly currently are testing a long-term form of Byetta that would be injected once a week. Timed-release capsules in the injection dissolve at specific intervals to deliver a continuous supply of the drug to the patient.)

The FDA's desire to scrutinize saxagliptin and liraglutide comes from its December 2008 directive calling for all new diabetes drug treatments to demonstrate that they do not increase cardiovascular risks.

Among the new testing conditions requested by the agency is the inclusion of older, sicker diabetes patients who are at higher risk of having a heart attack or stroke. Additionally, it is asking that drug studies follow patients for up to two years, versus the current three to six months.

Because both drugs were submitted to the FDA before issuance of the new December guidelines, there is some question about whether the agency will request more clinical data from the manufacturers.

Categories: Blood Glucose, Blood Sugar, Byetta, Diabetes, Diabetes, Insulin, Novo Nordisk, Type 2 Issues, Type 2 Medications

Comments

Posted by Mahalingam Kuppuswami on 4 June 2009

Dear Sir, I am thankful for new information.I am doing service to the Diabetics as Diabetes Healthcare Professional .Iwould like to know the instances of Reversal or Cure of Type 2 Diabetes Mellitus .Thank you ,Professor. Mahalingam Kuppuswami

Add your comments about this article below. You can add comments as a registered user or anonymously. If you choose to post anonymously your comments will be sent to our moderator for approval before they appear on this page. If you choose to post as a registered user your comments will appear instantly.

When voicing your views via the comment feature, please respect the Diabetes Health community by refraining from comments that could be considered offensive to other people. Diabetes Health reserves the right to remove comments when necessary to maintain the cordial voice of the diabetes community.

For your privacy and protection, we ask that you do not include personal details such as address or telephone number in any comments posted.

Don't have your Diabetes Health Username? Register now and add your comments to all our content.

Have Your Say...

Registered User Anonymous

Your Name:	Your Email:	X

Recipient's Name:	Recipient's Email:

Your Chosen Username:	Your Email Address:

Chosen Password:	Confirm Password:

Email to a Friend

FDA Poised to Review Two New Drugs for Type 2 Diabetes

You May Also Be Interested In...

Comments

Register...

Have Your Say...

Diabetes Health

Topics

Topics

Topics

Diabetes Health Medical Disclaimer

Comment: