Navigation Links
FDA Approves Combination Therapy Juvisync
Date:10/7/2011

SILVER SPRING, Md., Oct. 7, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Juvisync (sitagliptin and simvastatin), a fixed-dose combination (FDC) prescription medication that contains two previously approved medicines in one tablet for use in adults who need both sitagliptin and simvastatin.

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

About 20 million people in the United States have type 2 diabetes, and they often have high cholesterol levels as well. These conditions can lead to increased risk of heart disease, stroke, kidney disease and blindness, among other chronic conditions, particularly if left untreated or poorly treated.  

Sitagliptin is a dipeptidyl peptidase 4 (DPP-4) inhibitor that enhances the body's own ability to lower elevated blood sugar and is approved for use in combination with diet and exercise to improve glycemic control in adults with type 2 diabetes. Simvastatin is an HMG-CoA reductase inhibitor, or statin, approved for use with diet and exercise to reduce the amount of "bad cholesterol" (low-density lipoprotein cholesterol or LDL-C) in the blood.

"This is the first product to combine a type 2 diabetes drug with a cholesterol lowering drug in one tablet," said Mary H. Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "However, to ensure safe and effective use of this product, tablets containing different doses of sitagliptin and simvastatin in fixed-dose combination have been developed to meet the different needs of individual patients.  Dose selection should factor in what other drugs the patient is taking."

This FDC is based on substantial experience with both sitagliptin and simvastatin, and the ability of the single tablet to deliver similar amounts of the drugs to the bloodstream as when sitagliptin and simvastatin are taken separately. Juvisync is a convenience combination and should only be prescribed when it is appropriate for a patient to be placed on both of these drugs.

Juvisync was approved in dosage strengths for sitagliptin/simvastatin of 100 mg/10 mg, 100 mg/20 mg and 100 mg/40 mg. The company has committed to develop FDC tablets with the sitagliptin 50 mg dose, as Juvisync 50 mg/10 mg, 50 mg/20 mg and 50 mg/40 mg. Pending availability of the FDC tablets containing 50 mg of sitagliptin, patients who require this dose should continue to use the single ingredient sitagliptin tablet. There is no plan to develop FDCs with the sitagliptin 25 mg dose as use of this dose is quite low.

Simvastatin is currently marketed in dosage strengths of 5, 10, 20, 40, and 80 mg. Due to recent restrictions placed on the use of the 80 mg dose because of a higher risk of muscle toxicity, there will not be a FDC using this dose. There is also no plan to develop FDCs with the simvastatin 5 mg dose as use of this dose is quite low as well.

The FDA has recently become aware of the potential for statins to increase blood sugar levels in patients with type 2 diabetes. This risk appears very small and is outweighed by the benefits of statins for reducing heart disease in diabetes. However, the prescribing information for Juvisync will inform doctors of this possible side effect. The company will also be required to conduct a post-marketing clinical trial comparing the glucose lowering ability of sitagliptin alone compared to sitagliptin given with simvastatin.

Juvisync is approved with a Medication Guide that provides important information to patients. The most common side effects of Juvisync include upper respiratory infection; stuffy or runny nose and sore throat; headache; muscle and stomach pain; constipation; and nausea.

Juvisync is manufactured by MSD International GmbH Clonmel, Co. in Tipperary, Ireland.

For more information:

Approved Drugs: Questions and Answers
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

Sitagliptin Information
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm183768.htm

Simvastatin Information
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203669.htm

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Morgan Liscinsky, 301-796-0397, morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Cialis to Treat Benign Prostatic Hyperplasia
2. FDA Approves Remicade to Treat Ulcerative Colitis in Children Older Than 6 Years
3. FDA Approves Soliris for Rare Pediatric Blood Disorder
4. FDA Approves New Indications for Prolia® (Denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
5. FDA Approves Xalkori with Companion Diagnostic for a Type of Late-stage Lung Cancer
6. FDA Approves Firazyr To Treat Acute Attacks of Hereditary Angioedema
7. FDA Approves Adcetris to Treat Two Types of Lymphoma
8. FDA Approves the First Specific Treatment for Scorpion Stings
9. Cardinal Health Board of Directors Approves Cash Dividend, Elects David P. King as Director
10. FDA Tentatively Approves Intellijects Lead Product, e-cue™
11. FDA Approves New Medicine BRILINTA™ (Ticagrelor) for Use in the US
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/12/2016)... PAULO , Feb. 12, 2016 ... commenced a cash tender offer (the "Tender Offer") ... million outstanding aggregate principal amount of its 6.500% ... and ISIN Nos. US44915JAA88/ USP5246AAF05) (the "Notes"). In ... soliciting (the "Consent Solicitation") consents (the "Consents") of ...
(Date:2/12/2016)... PLATTSBURGH, NY , Feb. 12, 2016 /PRNewswire/ - Demers Ambulances ... Florida to Okaloosa County ... 164 Type III ambulances and one LT2 van. Quality Emergency ... Demers dealer, is responsible for the sale.  This is the ... Benoit LaFortune , Executive Vice President at Demers. --> ...
(Date:2/12/2016)... 2016  SI-BONE, Inc., a medical device company that pioneered the ... invasive surgical (MIS) device indicated for fusion for certain disorders of ... the Medicare Administrative Contractor (MAC) covering the states of ... , Massachusetts , Minnesota ... , Rhode Island , Vermont ...
Breaking Medicine Technology:
(Date:2/13/2016)... ... February 13, 2016 , ... ... becomes the first in the area to offer AngioPlex™ Optical Coherence Tomography (OCT) ... disease, such as macular degeneration, diabetic retinopathy, and other vascular conditions. , In ...
(Date:2/13/2016)... ... February 13, 2016 , ... The National Association for Children ... organization representing the growing community of recovering individuals (now over 23 million), to ... in policies addressing addiction. , Although many of the presidential candidates of ...
(Date:2/13/2016)... ... February 13, 2016 , ... The producers of Enterprises TV ... , The increasingly modern world of instantaneous consumption proves very convenient for businesses. ... such as oil and coal, which pollutes our air, water, and soil. It can ...
(Date:2/13/2016)... ... February 13, 2016 , ... When an Au Pair comes all the way ... they are in for and they are often worried things won’t go well. More often ... for. This year’s Au Pair of the Year winner’s all commented how their Au Pairs ...
(Date:2/12/2016)... CA (PRWEB) , ... February 12, 2016 , ... According ... hernia surgeries are beginning to account for a significant portion of hernia repairs throughout ... Towfigh of the Beverly Hills Hernia Center notes that this trend has not only ...
Breaking Medicine News(10 mins):