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Last Update: 21-Feb-12 11:32 ET
Corcept Therapeutics +49% Following News Late Friday That The FDA Approved Korlym
Late Friday, Corcept Therapeutics (CORT $4.50 +1.47) announced the FDA approved Korlym as a once-daily oral medicine to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery. Clinical trial results supporting fda approval resulted from an uncontrolled, open-label, multi-center, 24-week phase III study of 50 patients who had endogenous Cushing's syndrome and were either not eligible for or had relapsed from surgery and were either glucose intolerant (29 patients) or had hypertension (21 patients).
Within the glucose intolerant group, 60% of patients had a greater than 25% reduction from baseline in the area under the curve in the oral glucose tolerance test. In this group, mean hemoglobin A1C was reduced from 7.4% to 6.3% . All 14 patients with above-normal HbA1C levels at baseline experienced reductions. Eight of these 14 normalized their HbA1C. Antidiabetic medications were reduced in seven of the 15 patients with diabetes mellitus type 2 and remained constant in the others. Patients who responded to therapy were allowed enrollment in an extension trial. Eighty-eight percent of the patients who completed the trial chose to do so.
Within the glucose intolerant group, 60% of patients had a greater than 25% reduction from baseline in the area under the curve in the oral glucose tolerance test. In this group, mean hemoglobin A1C was reduced from 7.4% to 6.3% . All 14 patients with above-normal HbA1C levels at baseline experienced reductions. Eight of these 14 normalized their HbA1C. Antidiabetic medications were reduced in seven of the 15 patients with diabetes mellitus type 2 and remained constant in the others. Patients who responded to therapy were allowed enrollment in an extension trial. Eighty-eight percent of the patients who completed the trial chose to do so.
