Troglitazone Approved In Second Market, The USA

The US Food and Drug Administration has approved Warner-Lambert's newdiabetes drug Rezulin (troglitazone) for the treatment of type II diabetics who are poorly controlled on insulin therapy. Rezulin is the first antidiabetes drug designed to target insulin resistance, the underlying cause of type II diabetes, notes W-L.

The drug is indicated for use in "patients with type II diabetes currently on insulin whose hyperglycemia is inadequately controlled (hemoglobin A1c levels greater than 8.5%) despite insulin therapy of over 30 units per day given as multiple injections." The FDA notes that the drug may be used in the treatment of approximately one million type II diabetics in the USA who do not respond adequately to oral medication or insulin. However, considerable off-label use in other type II diabetics is expected.

Expanded Use Sought The new drug is a thiazolidinedione, and is the first in its chemical class to be approved in the USA. Indeed, the USA is only the second country to approve the drug, after Japan, where it has been price-listed. A launch in the USA is expected in March, and Warner-Lambert's Parke-Davis subsidiary, which will market the drug, says it is planning to file a supplemental New Drug Application to expand the use of troglitazone to include all type II patients, on its own or in combination with sulfonylureas.