Orphan Drug Designation for Digoxin Immune Fab (Ovine) for Severe Preeclampsia and Eclampsia

Glenveigh Medical announced that the FDA has granted its request for orphan drug designation for digoxin immune fab (ovine) to treat severe preeclampsia and eclampsia.

Preeclampsia is a condition in pregnant women that is characterized by high blood pressure and excess protein in the urine in the second and third trimesters of pregnancy. Severe preeclampsia and eclampsia represent the most advanced stages of the disease in which pregnant women can suffer from seizures and organ failure. Although the exact etiology of preeclampsia is unknown, a number of biologically active factors have been implicated. One factor, endogenous digitalis-like factor (EDLF), occupies the digitalis-binding site and has been found to inhibit the sodium pump, which itself has recently been shown to play an important physiological role in blood-pressure regulation. In addition, studies show that EDLF is increased in the circulation of women with preeclampsia and its effects, including vasoconstriction and hypertension, may be reversed by anti-digoxin antibodies.

Digoxin immune fab (ovine) (Digibind; GlaxoSmithKline Pharmaceuticals, Digifab; Savage Laboratories) is an existing biologic approved for use in cases of digoxin toxicity.

For more information, call (423) 933-3939 or visit www.glenveigh.com.