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Tue, 17 Oct 2006 21:32:34 EDT

By Susan Heavey

WASHINGTON (Reuters) - A new diabetes drug that helps the body control blood sugar won U.S. approval on Tuesday, making it the first in a new class of pills that treat the disease without weight gain seen with some other drugs.

The Food and Drug Administration approved Merck & Co. Inc's oral diabetes drug Januvia to treat adults with type 2 diabetes, which affects the majority of the nearly 21 million Americans with the disease.

It occurs when the body builds resistance to insulin needed to break down food and causes blood sugar levels to be too high. Obesity is a major risk factor for the disease, which if not controlled can lead to heart problems, blindness and other complications, so drugs that do not add pounds are expected to enhance patient compliance and physician acceptance.

Januvia, known generically as sitagliptin, can be used alone or along with other commonly used oral diabetes drugs such as metformin and PPAR agonists, the FDA said. The PPAR agonists, also known as TZDs, are sold under the brand names Avandia by GlaxoSmithKline and Actos from Eli Lilly and Co. and Takeda Pharmaceutical Co.

"Being able to combine Januvia with two of the more popular treatment options gives another way to control folks who otherwise can't be adequately controlled on a single agent," Dr. Robert Meyer, a director of the FDA's Office of Drug Evaluation, told reporters on a conference call.

Once-a-day Januvia is expected to face competition from Novartis AG's rival medicine Galvus, which is awaiting FDA approval, possibly next month.

Both drugs belong to a new class of medicines called dipeptidyl peptidase IV, or DPP-4, inhibitors that work to enhance the body's own ability to lower blood sugar. In clinical trials, patients taking the drugs did not gain weight.

While they can be used with the TZDs, which make patients less resistant to insulin, the new drugs may also compete directly with Avandia and Actos, which have been linked to water retention and weight gain.

"Despite the drugs that are out there, the vast majority of patients out there are not at (their) treatment goal," Jay Galeota, head of Merck's global diabetes franchise, told Reuters last week.

The FDA said it will ask Merck to conduct post-marketing studies of Januvia in combination with another common diabetes treatment called sulfonylureas, and with insulin, which tends to be used in type 2 diabetics further along in the disease than those just taking oral medications.

"We will continue to get those data and we will update the label as that safety data becomes available to us," said Dr. Mary Parks, director of the FDA's Division of Metabolism and Endocrine Products.

Analysts expect Januvia and Galvus could each generate more than $1 billion in annual sales.

Whitehouse Station, New Jersey-based Merck said Januvia would be in pharmacies "in the near future" and would cost $4.86 per tablet.

"If (Merck) can ship fairly quickly here, that month may be important, just to get their samples out first and get it into doctors' hands first," Natexis Bleichroeder analyst Jon LeCroy said of the potential jump Januvia could have on Galvus. LeCroy projected annual Januvia sales of $1.6 billion by 2010.

A survey of about 60 physicians conducted by Reuters Primary Research showed the vast majority of doctors intend to start prescribing Januvia and Galvus as soon as possible.

Dr. Stuart Weiss, a New York University Medical Center endocrinologist, said the drug's ability to control blood sugar spikes without added weight gain was a big draw.

"In the face of a diabetes epidemic, this drug... is particularly an inviting choice," said Weiss, who has consulted for several Merck competitors, including Novartis.

FDA officials also said the new class of drugs do not appear to have issues with hypoglycemia, or dangerously low blood sugar, as seen with some older diabetes treatments.

Shares of Merck were up 8 cents at $43.84 on the New York Stock Exchange. (Additional reporting by Julie Steenhuysen in Chicago and Lewis Krauskopf and Bill Berkrot in New York)