Advisory committee OKs new oral diabetes drug
Troglitazone, which will be marketed as Rezulin by Warner-Lambert, appears to be on the fast track for approval by the U.S. Food and Drug Administration. An FDS panel of reviewers has recommended approval for the drug intended to reduce type II diabetics’ reliance on insulin.
The drug appears to work well in patients who have previously been insulin resistant or who have failed to achieve adequate control of blood glucose levels with sulfonylurea.
In a six-month trial involving 351 patients, 57% taking a 600 mg dose of troglitazone achieved levels of HbA1c, a blood glucose measure taken over eight to 12 weeks, below 8%. The American Diabetes Association considers an HbA1c level of 7% to be normal.