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【drug-news】Merk糖尿病药物获得美国政府许可
Merck diabetes drug wins federal approval in the U.S.
13:57:34 EDT Oct 17, 2006
Canadian Press: ANDREW BRIDGES
WASHINGTON (AP) - Diabetics in the United States gained a new way of controlling their blood sugar levels Tuesday with federal approval of a novel pill for Type 2 diabetes.
The Food and Drug Administration said it approved Januvia, which enhances the body's own ability to lower blood sugar levels, after clinical trials showing the new pill works just as well as older diabetes drugs, but with fewer side effects like weight gain. The drug is made by Merck and Co. Inc.
It is not available in Canada.
The new drug's cost in the U.S. may limit its use, however. Merck did not immediately disclose what it would charge for Januvia, but it is expected to cost between US$3 and US$6 a day. Older diabetes drugs can cost 50 cents a day.
Januvia, also known as sitagliptin phosphate, works with a one-two punch: It increases levels of a hormone that triggers the pancreas to produce more insulin to process blood sugar while simultaneously signalling the liver to quit making glucose. The pill does that by blocking production of an enzyme, called DPP-4, that normally inactivates that hormone.
Januvia is unlike any other oral drug for treating Type 2 diabetes. However, Novartis AG hopes to win FDA approval for a similar drug later this year.
In Type 2 diabetes, patients either don't produce enough insulin or cells in the body ignore it. Insulin is needed to process sugar. Without it, blood sugar levels soar.
The FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with Type 2 diabetes, alone or in combination with other commonly prescribed drugs.
"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."
American Diabetes Association guidelines suggest diabetics cut their levels of an averaged measure of blood sugar levels, called A1c, to less than seven per cent. Many, if not most, diabetics exceed that threshold. Helping them drop below it could reduce their risk of serious complications, like kidney failure and amputations, the diabetes group says.
At a diabetes conference in June, Merck said Januvia lowered blood sugar levels by 0.67 per cent in a yearlong trial, or just as much as another, older drug, glipizide. Roughly two-thirds of patients reached the ADA's 7 per cent goal.
Most importantly, Merck said the Januvia patients also lost weight and experienced fewer episodes of excessively low blood sugar than those on glipizide, a member of the sulfonylurea class of drugs. Excess weight is a common problem in Type 2 patients.
Analysts have predicted Januvia sales could reach US$1 billion in 2009 for Whitehouse, N.J.-based Merck.
Merck hopes to win FDA approval in late March for another pill, called MK-0431, that combines Januvia and the diabetes drug metformin.
"There is a huge need for additional therapeutic options in this marketplace," said Jay Galeota, who manages Merck's global diabetes drug business.
More than 230 million people worldwide have diabetes, up from just 30 million in 1985, according to the International Diabetes Federation. Diabetes is expected to affect 350 million people by 2025. 我来试试
我不用试试了，呵呵 FDA News
FOR IMMEDIATE RELEASE
P06-169
October 17, 2006
Media Inquiries:
Laura Alvey, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Approves New Treatment for Diabetes
First in a New Class of Diabetes Drugs
The Food and Drug Administration (FDA) announced today the approval of Januvia (sitagliptin phosphate) Tablets, the first diabetes treatment approved in a new class of drugs known as DPP-4 inhibitors that enhances the body's own ability to lower elevated blood sugar.
FDA approved Januvia for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes, alone or in combination with two other commonly prescribed oral diabetes medications, metformin or a PPAR (peroxisome proliferator-activated receptor gamma) agonist, when either of these drugs alone, along with diet and exercise, don't provide adequate blood sugar control.
"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."
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作者:admin@医学,生命科学 2010-12-13 05:11
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