Rezulin Cleared For Additional Indications

Warner-Lambert has been granted clearance from the US Food and DrugAdministration to market the antidiabetes drug Rezulin (troglitazone) as either a monotherapy or as a combination therapy with sulfonylureas in the treatment of type II diabetes. This approval comes only six months after the company received notification that the drug had been approved for use in type II patients poorly controlled on insulin (Marketletter February 10).

In clinical trials, 60% of patients receiving Rezulin 600mg plus sulfonylurea were able to achieve hemoglobin A1c levels of 8% or less, versus 10% on sulfonylurea alone. Furthermore, 57% of patients receiving Rezulin 600mg plus insulin achieved this target, against only 11% of patients receiving insulin as a monotherapy.

This latest approval brings the USA in line with the UK, where the drug was recently approved under the brand name Romozin for use as a monotherapy for the treatment of patients inadequately controlled on diet alone, as well as in combination with insulin or sulfonylureas to improve glycemic control in type II diabetics (Marketletter August 4).