Bio-Technology General regulatory update

BTGC (Iselin, NJ) submitted an NDA to the FDA for Hepandrin (oxandrolone) to treat alcoholic hepatitis. The submission was based on two studies conducted by the Department of Veterans Affairs. In a study of 127 paients with moderate to severe alcoholic hepatitis and moderate malnutrition, Hepandrin plus a nutritional supplement reduced the six-month mortality rate. Mortality was 18 percent for treated patients and 38 percent for placebo (p=0.012). The mean survival time of the treatment group was 41 months vs. 22 months in the placebo group.

Hepandrin had no effect on mortality for patients with severe malnutrition or those with moderate malnutrition and inadequate nutritional intake. There was also no effect in patients with adequate nutritional intake who weren't given Hepandrin. ...