Merck’s new class of diabetes drug wins FDA approval

Here is a reason to smile for the sufferers of type 2 diabetes, a serious and debilitating disease that becomes progressively more common with age and obesity. Merck & Co. on Tuesday added one more option for the diabetics by announcing the federal approval of its novel drug for type 2 diabetes.

The Whitehouse Station, New Jersey-based pharmaceutical company yesterday announced that the U.S. Food and Drug Administration (FDA) approved Januvia™ (sitagliptin phosphate), the first in a new class of oral medications that enhance the body's own ability to lower blood sugar when it is elevated.

The recently approved drug is the only dipeptidyl peptidase-4 (DPP-4) inhibitor available in the United States for the treatment of type 2 diabetes.

The FDA said that after going through the clinical trials, showing the new drug works just like the older diabetes drugs but with lesser side effects such as weight gain, it approved Januvia, a once-daily tablet. These tablets are expected to be priced at $4.86 a day or about $145 a month.

Januvia got the federal approval for use in addition to diet and exercise to improve blood sugar levels in patients with type 2 diabetes. It can be taken alone or in combination with two other commonly prescribed oral diabetes medications, Metformin, Actos and Avandia.

The recently approved drug was tried out on a total of 2,719 sufferers of type 2 diabetes. The studies, which lasted from 12 weeks to more than a year, showed improved blood sugar control when Januvia was used alone or in patients not satisfactorily managed with metformin or a PPAR agonist.

According to the FDA, the most common side effects of Januvia in clinical studies were upper-respiratory-tract infection, sore throat and diarrhea.

Drug manufacturer, Merck & Co. stated the working of Januvia on its website telling that it enhances a natural body system dubbed the incretin system, which helps to regulate glucose by influencing the beta cells and alpha cells in the pancreas. Through DPP-4 inhibition, this drug works only when blood sugar is elevated to address diminished insulin due to beta-cell dysfunction and uncontrolled production of glucose by the liver due to alpha-cell and beta-cell dysfunction.

Type 2 diabetes affects at least 175 million people worldwide and about 20 million alone in America. Diabetes is expected to affect 350 million people by 2025.

On the significance of the approval of Januvia for the sufferers in US, Dr. Steven Galson, Director of FDA’s Center for Drug Evaluation and Research said, “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.”

“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,” DR. Galson added.

Market analysts have made predictions that Januvia sales could reach $1 billion in 2009 for the global research-driven pharmaceutical company, Merck.

The Pharma Company expects to secure FDA approval in 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 looks after Merck's global diabetes-drug business.