FDA Clears Drug That Treats Type 2 Diabetes

The Food and Drug Administration said it approved Merck & Co.'s drug Januvia to treat Type 2 diabetes.

Januvia is the first in a new class of diabetes medicine known as DPP-4 inhibitors. The drug works by enhancing the body's own ability to lower blood sugar, or glucose, when it is elevated. Swiss-based Novartis AG has a similar drug, Galvus, which is awaiting FDA approval.

Analysts have predicted both drugs could easily reach blockbuster status of more than $1 billion in annual sales by 2010 as long as no major safety issues emerge.

Merck priced the once-daily tablet at $4.86 apiece.

About 21 million people in the U.S. have diabetes, a disease that is characterized by high blood glucose levels that result from the body's inability to produce insulin, in the case of Type 1 diabetes, and to use or to produce enough insulin, in the case of Type 2 diabetes.

Type 2 diabetes is the more common form of the disease and most often occurs in people who are older than 45 and overweight, although there has been an increase in younger patients in recent years. Many people with Type 2 diabetes can control their blood sugar levels through diet and exercise and by taking medications. In more severe cases of Type 2 diabetes, patients also take insulin. Type 1 diabetes, often diagnosed in childhood, requires people to take insulin to manage their blood sugar levels. Patients with diabetes can develop heart and kidney disease, blindness, and vascular or neurological problems that can lead to amputation.

DPP-4 inhibitors work in a different manner than blood-glucose lowering drugs currently on the market, including sulfonylurea drugs, which stimulate the pancreas to release insulin, and metformin, which works on the liver to reduce blood sugar.

Two other drugs on the market, Actos by Takeda Pharmaceutical Co. and Eli Lilly & Co., and Avandia by GlaxoSmithKline PLC, make the body more sensitive to insulin. Because of the drugs' differing effects to lower blood sugar, many of them are combined in treatments.

The FDA approved Januvia for use in addition to diet and exercise, alone or in combination with metformin, or Actos or Avandia. Mary Parks, director of the FDA's Division of Metabolism and Endocrine Products, said in a press conference that the agency is asking Merck to conduct two studies involving the use of Januvia in combination with sulfonylurea drugs and insulin.

Januvia has been considered one of the most important projects for Merck, Whitehouse Station, N.J., as it recovers from the loss of its painkiller Vioxx, which was pulled from the market after a study linked it to an increased risk of heart attack and stroke.

"We now have an option for physicians of a new and novel drug which has powerful glucose lowering efficacy without causing many of the side effects of current agents," said John Amatruda, vice president of clinical research for Merck. Dr. Amatruda said side effects of Januvia are similar to placebo, or fake pill, and include runny nose, sore throat and diarrhea. Unlike current diabetes drugs on the market, DPP-4 inhibitors don't cause weight gain, which is seen as a major benefit, as the majority of diabetes Type 2 patients are already overweight.

Merck will likely have to share the market of DPP-4 inhibitors with Novartis, which is set to hear from the FDA on Galvus next month. Representatives for both Merck and Novartis declined to draw comparisons between the two drugs, saying they haven't been studied head-to-head.

"If there are other products that get approved at some point in the future, that only reinforces the fact that we believe that this class of drugs, DPP-4 inhibitors, is a major advance for the treatment of this disease," said Jay Galeota, general manager of Merck's global diabetes franchise. Januvia is already approved in Mexico. "With the U.S., and other countries soon to follow, we expect to have a rollout globally over the near future," he said.