近日,默克公司宣布，美FDA已经接受了该公司2型糖尿病治疗药物JANUVIA 的新药上市申请，该药已进入标准的审批程序，预计在2006年10月中旬可收到美国FDA的审批结果。默克公司表示，将同时在美国以外的地区递交该药的上市申请。JANUVIA是一种口服二肽基酶IV(DPP-IV)抑制剂，用于治疗2型糖尿病，属非胰岛素治疗药物。 分析人士认为，由于DPP-IV抑制剂没有体重增加和水肿的不良反应，一旦获得批准，JANUVIA将得到广泛的应用。 New Diabetes Drug Approved by the FDA A new oral medication called Januvia (sitagliptin phosphate) has been approved by the FDA for management of Type 2 diabetes. It's the first in a new class of drugs called DPP-4 inhibitors. Januvia lowers blood sugar levels by blocking the enzyme known as dipeptidyl peptidase IV or DPP-4. DPP-4 is responsible for breaking down the proteins that stimulate the insulin producing cells after a meal. If DPP-4 is inhibited, then the proteins can activate the release of insulin for a longer period of time, thereby lowering the glucose level in the blood. Januvia showed good results in recent trials both in combination with other drugs, like metformin, and also by itself. It is prescribed for Type 2 diabetes only. For some people, diet, exercise and conventional medications are not enough to keep blood glucose levels in a good range. Januvia has been successful in clinical trials at helping to lower them when traditional methods aren't enough. It cannot work with Type 1 because most of the funtioning insulin producing cells in the pancreas have been destroyed. It also has not been tested on Type 2 patients under 18 years of age. Because Januvia works on prolonging the stimulation of insulin production, the risk of hypoglycemia is unlikely. Also there is little risk of weight gain. The most commonly reported side effects include upper respiratory infection, sore throat and/or headache. "For the millions of Americans with type 2 diabetes, who continue to have inadequate blood sugar control, the approval of Januvia marks an important advance in the fight against diabetes," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "We now have another new option that treats the disease in an entirely new way that can be added to existing treatment regimens to help patients gain more control over their blood sugar levels." Januvia will be prescribed in a dose of 100 mg. once a day. If the patient is compromised by severe renal insufficiency, the dosage may be adjusted to 50 mg. per day. Merck & Co., Inc., the company who manufactures Januvia has set the price of Januvia at $4.86 per 100 mg. tablet. This works out to a little less than $150.00 a month. Januvia should be available at pharmacies soon. Diabetes patients who might be prescribed Januvia should check with their health insurance plan to see what the coverage will be.