Navigation Links
FDA Approves 1st in New Class of Type 2 Diabetes Drugs
Date:3/29/2013

FRIDAY, March 29 (HealthDay News) -- The first in a new class of type 2 diabetes drugs was approved Friday by the U.S. Food and Drug Administration.

Invokana (canaglifozin) tablets are to be taken, in tandem with a healthy diet and exercise, to improve blood sugar control in adults with type 2 diabetes.

Invokana belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It works by blocking the reabsorption of glucose (sugar) by the kidney and increasing glucose excretions in urine, the FDA said in a news release.

"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," Dr. Mary Parks, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in the news release.

About 24 million Americans have type 2 diabetes, and it accounts for more than 90 percent of diabetes cases diagnosed in the United States, the FDA said. If blood sugar levels are not carefully controlled, there is an increased risk for serious complications, including heart disease, blindness, and nerve and kidney damage, the agency added.

The FDA approval is based on the findings of nine clinical trials involving more than 10,000 patients. Patients who took the drug showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting blood sugar levels.

Invokana should not be used by people with type 1 diabetes or people with type 2 diabetes who have increased ketones in their blood or urine (diabetic ketoacidosis), severe kidney disease, kidney failure or who are on dialysis, the FDA said.

The agency told drug maker Janssen Pharmaceuticals that it must conduct five post-approval studies of the drug to determine the risk of problems such as heart disease, cancer, pancreatitis, liver abnormalities and pregnancy complications.

The most common side effects of Invokana are vaginal yeast infections and urinary tract infections. It may also cause dizziness and fainting.

More information

The U.S. National Institute of Diabetes and Digestive and Kidney Diseases has more about type 2 diabetes.

-- Robert Preidt

SOURCE: U.S. Food and Drug Administration, news release, March 29, 2013


'/>"/>
Copyright©2012 ScoutNews,LLC.
All rights reserved  

Related medicine news :

1. FDA Approves Generic Versions of Plavix
2. FDA Approves Combo Shot for Meningitis, Hib in Kids
3. FDA Approves SonixGPS Needle Guidance Technology for Vascular Access Procedures
4. FDA Approves First New Weight-Loss Drug in More Than a Decade
5. FDA Approves 1st Pill to Help Prevent HIV Infection
6. FDA Approves 2nd New Weight-Loss Drug
7. FDA Approves Flu Vaccine for Coming Season
8. FDA Approves New Once-a-Day HIV Pill
9. FDA Approves New Type of Flu Vaccine
10. Environmental Protection Agency Approves MOMS by OdorXit as a Disinfectant
11. FDA Approves 1st Skin Patch to Combat Migraines
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Approves 1st in New Class of Type 2 Diabetes Drugs
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which ... evacuation of the facility as part of a disaster drill on October 3rd. , ... and Shelton City Emergency Manager, as well as the Connecticut Long Term Care ...
(Date:10/13/2017)... ... 2017 , ... Yisrayl Hawkins, Pastor and Overseer at The House of Yahweh, ... and least understood books in the Holy Scriptures, Revelation. The Book of Revelation paints ... for centuries. Many have tossed it off as mere rubbish, but Yisrayl Hawkins says ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... ... advisory services for healthcare compliance program management, will showcase a range of technology ... Association for Assisted Living (NCAL) Convention and Expo to be held October 14–18, ...
(Date:10/12/2017)... ... October 12, 2017 , ... The American College of Medical Informatics (ACMI) will ... during the Opening Session of AMIA’s Annual Symposium in Washington, D.C. AMIA’s Annual ... F. Collen, a pioneer in the field of medical informatics, this prestigious award is ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts ... Washington, D.C., for the 49th Congress of the International Society of Paediatric Oncology ... of the Center for Cancer and Blood Disorders at Children’s National, and ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... -- Halo Labs announces the European launch of their new low ... MIBio 2017 in Cambridge, U.K on October ... biopharmaceutical samples with unprecedented speed and sensitivity while using far less ... Imaging. ... analysis system ...
(Date:9/27/2017)... 2017  Commended for their devotion to personalized service, SMP ... number one in the South Florida Business Journal,s 50 Fastest-Growing ... yearly list, the national specialty pharmacy has found its niche.  ... will soon be honored by SFBJ as the 2017 Power ... Set to receive his award in October, Bardisa said of ...
(Date:9/23/2017)... Pa. , Sept. 22, 2017 Janssen ... a complete response letter from the U.S. Food and ... seeking approval of sirukumab for the treatment of moderately ... letter indicates additional clinical data are needed to further ... moderately to severely active RA. ...
Breaking Medicine Technology: