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Health

New diabetes drug could help millions

Merck's Januvia is the first of a new class called DPP-4 inhibitors to get FDA approval.

By STEPHEN NOHLGREN
Published October 18, 2006

Tuesday brought some good news for the 20-million Americans, or roughly one in 15, and more than 200-million people globally who suffer from diabetes.

Left unchecked, the disease leads to heart attacks, strokes, kidney disease, blindness and amputations. It is on the rise worldwide.

The U.S. Food and Drug Administration on Tuesday approved the use of Januvia, the first of a new class of drugs that fight Type 2 diabetes, the most common form. This gives doctors and patients more options when current treatments don't work.

Here are some details:

What is diabetes?

A disease marked by excess blood sugar. Insulin is a hormone that stabilizes blood sugar and helps transport it to cells, where the body uses it for fuel.

With diabetes, either the pancreas produces too little insulin or the body builds up a resistance to insulin and won't process the sugar. Sugar levels rise in the blood and damage many of the body's organs.

Type 2 diabetes, previously called adult onset diabetes, makes up 90 percent to 95 percent of all diagnosed cases of the disease, which tends to strike overweight people, African-Americans, Hispanics and American Indians.

How is Type 2 diabetes treated?

In several ways. Diet and exercise, insulin shots and pills. Three common drugs - metformin, Actos and Avandia - fight insulin resistance. They are often used in combination with other drugs that stimulate the pancreas to produce more insulin.

How is Januvia different?

Made by Merck, Januvia is a new type of drug called a DPP-4 inhibitor. It helps the body maintain production of hormones called incretins, which instruct the pancreas how to react when food hits the intestinal tract. Diabetics have reduced levels of incretins. Januvia blocks an enzyme that breaks down incretins.

More incretins mean the pancreas has a better chance to function normally, both by increasing insulin when food arrives and by decreasing a substance called glucagon, which tells the liver to produce glucose. Both functions help the body stabilize blood sugar.

Novartis also has a DPP-4 inhibitor in clinical trials, as do two Japanese manufacturers. Annual worldwide sales of diabetes drugs are expected to double to $20-billion over the next five years, as more people develop the disease and pharmaceutical companies continue to bring out new and more expensive treatments.

How important are these new drugs?

"Januvia marks an important advance in the fight against diabetes" by creating new options, said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.

Many diabetics do not stabilize completely with current treatments. Others respond well at first but later regress.

Januvia, taken alone, performed as well as other treatments during clinical trials. The FDA has also approved Januvia for use in combination with other treatments.

Does Januvia have side effects?

Some patients in clinical trials experienced upper respiratory problems like coughing, colds and runny noses. Others had diarrhea and nausea. Januvia did not cause the weight gain or fluid retention that patients sometimes experience with current treatments. Nor did Januvia create low blood sugar swings that current treatments sometimes cause.

What will Januvia cost?

It is a once-daily tablet. Januvia will cost $4.86 a day, adding about $1,800 to the annual cost of treatment. Analysts have projected sales at $1-billion in 2009. Jay Galeota, general manager of Merck's global diabetes division, said Merck planned to ship Januvia to pharmacies and offer samples to doctors' offices quickly.

How did the news affect Merck?

Optimism about Januvia has helped push Merck shares up 38 percent this year, compared with an 11 percent gain for the average large drug stock. Merck shares closed Tuesday at $43.96, up 20 cents - at their highest level since the company withdrew its arthritis drug Vioxx in September 2004 after a study linked Vioxx to heart attacks and strokes.

Sources: Associated Press, Los Angeles Times, New York Times, FDA, Merck, American Diabetes Association, Dr. M. Hamed Farooqui, medical director of the Joslin Diabetes Center at Mease Countryside Hospital

[Last modified October 18, 2006, 05:27:11]