New Type 2 Diabetes Drug Onglyza Approved

• Diabetes • • Drug News • Dec 05, 13

The FDA today approved Onglyza, a once-daily treatment for type 2 diabetes to be taken in combination with diet and exercise.

Onglyza, made by Bristol-Myers Squibb and distributed by Bristol-Myers Squibb and AstraZeneca Pharmaceuticals, was tested in diabetes patients at relatively low risk of heart disease. The FDA approval requires Bristol-Myers Squibb to conduct a postmarketing study to evaluate the drug’s heart safety in higher-risk patients.

Onglyza carries the generic name saxagliptin. It belongs to a class of type 2 diabetes drugs called DPP-4 inhibitors. The first drug in this class, Merck’s Januvia, was approved in 2006. Like Onglyza, Januvia is taken once daily and is to be used in combination with diet and exercise.

Another DPP-4 inhibitor, Takeda’s alogliptin, was rejected by the FDA last month. The U.S. regulatory agency said the company has to provide more data on heart risks before it can be approved. Takeda has said these additional studies will take two years.

All DPP-4 inhibitors work the same way, by blocking an enzyme that degrades GLP-1, a short-lived hormone that stimulates insulin release from the pancreas, thereby lowering blood sugar. Patients taking DPP-4 inhibitors have higher GLP-1 levels and lower blood sugar levels.

“Keeping blood sugar levels in adequate control is essential to the good health of the 24 million people in the United States with type 2 diabetes,” says Mary Parks, MD, director of the FDA’s Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research.

WHAT IS ONGLYZA?

ONGLYZA (saxagliptin) is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

ONGLYZA should not be used to treat people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).

If you have had inflammation of the pancreas (pancreatitis), it is not known if you have a higher chance of getting pancreatitis while taking ONGLYZA.

The most common side effects observed with Onglyza are upper respiratory tract infection, urinary tract infection, and headache. Other side effects include allergic-like reactions such as rash and hives.

Onglyza side effects

Get emergency medical help if you have any of these signs of an allergic reaction to Onglyza: hives, a purple or red skin rash that spreads and causes blistering and peeling; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

pain or burning when you urinate;

swelling in your hands, ankles, or feet; or

easy bruising or bleeding.

Common Onglyza side effects may include:

runny or stuffy nose, sore throat, cough; or

headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

The drug saxagliptin (trade name: Onglyza) has been approved also as monotherapy in Germany since July 2013 for certain adults with type 2 diabetes mellitus. It is an option when drug treatment is needed, but the drug metformin is not tolerated or cannot be used.

In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether saxagliptin offers an added benefit over the current standard therapy. Such an added benefit cannot be derived from the dossier, however, as the manufacturer did not submit any suitable data.
G-BA specified sulfonylurea as appropriate comparator therapy

Saxagliptin in combination with other drugs has already been available in Germany since 2009 and was already assessed by IQWiG as part of the assessment of the established drug market. Since the middle of this year, it can also be used as monotherapy. However, the precondition is that the patient has metformin intolerance or contraindication.

The Federal Joint Committee (G-BA) specified a sulfonylurea (glibenclamide or glimepiride) as appropriate comparator therapy.

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By Daniel J. DeNoon
WebMD Health News