Print | Email | Share | Comments (0)

Type 2: FDA OKs Canagliflozin But Has Concerns About Heart Risk

Diabetes Health Staff

Feb 1, 2013

In a 10-5 vote, an FDA panel has recommended that the agency approve the marketing of Johnson & Johnson's Invokana^TM (canagliflozin), an oral once-daily drug for treating type 2 diabetes in adults.

The recommendation follows an earlier determination by another FDA panel that the drug may slightly increase the risk of cardiovascular problems, including raised cholesterol levels.

FDA approval of Invokana would mark the first time that the class of drugs called SGLT2 (sodium glucose co-transporter 2) inhibitors will be offered on the U.S. market. The drugs work by increasing the amount of blood sugar that is excreted through urine.

In type 2 diabetes patients, the kidneys reabsorb greater amounts of glucose back into the body than people who do not have the disease. Scientists suspect that this reabsorption is one of the reasons why type 2 patients have higher blood sugar levels than non-patients.

Because it works on the kidneys, the agency panel also recommended that patients with impaired kidney function not take the drug. Also, extensive patient studies showed that canagliflozin increases the risk of urinary tract and genital area fungal infections caused by germs feeding on excreted blood sugar.

Johnson & Johnson's supporting data from a Phase 3 trial came from 10,285 patients enrolled in nine studies, which were divided according to several criteria: Patients taking 100 mg and 300 mg daily doses of canagliflozin or placebo; older patients; patients with moderate kidney damage; and patients at risk for cardiovascular disease.

Besides risks identified with the drug, data showed that canagliflozin had positive effects on weight loss and blood pressure.
The FDA had previously investigated another experimental SLGT2 inhibitor, dapagliflozin, from Bristol-Myers Squibb Co. and AstraZeneca PLC. However, citing concerns about possible liver damage and elevated rates of bladder and breast cancer, the agency did not approve the drug.

The agency will decide by March 31 whether it will approve U.S. sales of Invokana.

Categories: Blood Sugar, Diabetes Health, Diabetes Health Magazine, Diabetic, FDA, Insulin, Johnson and Johnson, Research

Comments

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

Type 2: FDA OKs Canagliflozin But Has Concerns About Heart Risk

You May Also Be Interested In...

Comments

Register...

Have Your Say...

Diabetes Health

Topics

Topics

Topics

Diabetes Health Medical Disclaimer

Comment: