Glenveigh Medical announced today that the FDA has designated Digoxin Immune Fab (DIF), a potential new therapy to treat severe preeclampsia, for Fast Track review.

Glenveigh received orphan drug designation for DIF from the FDA earlier this year. As many as 30 sites across the country could be involved in the upcoming pivotal study.

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.

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