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New Diabetes Drug Januvia Approved by FDA

Tara Dairman

October 20, 2006

The U.S. Food and Drug Administration (FDA) approved a new oral diabetes drug on Tuesday, October 17. The drug, sitagliptin (brand name Januvia), is manufactured by the pharmaceutical company Merck & Co., Inc., and is meant for use in people with Type 2 diabetes. Januvia is the first drug in a new class called dipeptidyl peptidase IV (or DPP-4) inhibitors to be approved.

DPP-4 inhibitors work by enhancing the body’s levels of a protein called GLP-1. This protein, in turn, stimulates the pancreas to produce more insulin and prevents the liver from producing glucose—but only when blood glucose levels are already elevated. This selectivity makes DPP-4 inhibitors much less likely to cause hypoglycemia (low blood glucose) than some older diabetes drugs.

Januvia is meant to be taken once a day and can be taken on its own or in addition to certain other diabetes medicines, namely metformin (Glucophage and other brand names), pioglitazone (Actos), and rosiglitazone (Avandia). One of its chief selling points will likely be that, according to clinical trials, it does not cause weight gain or severe side effects like hypoglycemia. In a study of over 2,000 people, the most common side effects were sore throat, diarrhea, and colds. This study also showed that Januvia lowered HbA1c (a measure of blood glucose control) by an average of 0.67%, the same amount as the older diabetes drug glipizide (Glucotrol and other brand names), which does tend to cause weight gain and hypoglycemia.

Januvia’s chief drawback for many people will likely be its price, which is $4.86 per day, or about $145 per month.

Merck is planning to ship Januvia to pharmacies and send free samples to doctors quickly, meaning that the drug should be available to people with diabetes very soon. A survey of 60 doctors conducted by Reuters showed that 90% plan to begin prescribing the drug right away.

Another drug in the DPP-4 class, called vildagliptin (Galvus), is expected to be approved later this year, possibly as soon as next month. Galvus is manufactured by the pharmaceutical company Novartis AG. Merck is also applying for FDA approval for a drug that combines Januvia with metformin.



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