FDA Approves Diabetes Treatment
FDA on Tuesday approved Merck's type 2 diabetes drug Januvia, the first in a new class of treatments called DPP-4 inhibitors, the Philadelphia Inquirer reports. FDA approved Januvia, a once-a-day pill, for use by itself or in combination with other oral drugs: metformin, a generic drug that is the most prescribed diabetes treatment, or TZDs such as GlaxoSmithKline's Avandia and Takeda Pharmaceuticals' Actos (Ginsberg, Philadelphia Inquirer, 10/18).
FDA approved Januvia for use in conjunction with a healthy diet and exercise (Kowsmann, Wall Street Journal, 10/18).
Januvia works by increasing levels of a protein called GLP-1. The protein stimulates the pancreas to produce insulin and discourages the liver from making glucose. The drug is effective only when blood sugar levels are already elevated, such as after a meal, thereby sharply reducing the risk of a rapid drop in blood sugar levels, known as hypoglycemia (Berenson, New York Times, 10/18).
Januvia was tested in 2,719 patients with type 2 diabetes in studies that ranged from 12 weeks to more than a year, and the drug was found to be effective at controlling blood sugar when taken alone or with the other drugs, FDA said. In addition, Januvia did not cause weight gain, as some other diabetes drugs do. Side effects included respiratory infection, sore throats and diarrhea (Manning/McCoy, USA Today, 10/18).
At a diabetes conference in June, Merck said Januvia lowered blood sugar levels by 0.67% over a year, the same amount as the older drug glipizide. About two-thirds of patients reached the American Diabetes Association's 7% benchmark for blood sugar levels, Merck said (AP/Washington Times, 10/18).
Merck said Januvia will cost slightly less than $5 per pill, or about $145 per month, which is similar to some existing treatments. Analysts predict that Januvia will achieve worldwide sales of nearly $2 billion by 2010, the New York Times reports.
Novartis expects to receive FDA approval for a similar drug, Galvus, later this year (New York Times, 10/18).