Trade Resources Industry Views The US FDA Has Granted Fast Track Review to Glenveigh Medical's Digoxin Immune Fab (DIF)

The US FDA Has Granted Fast Track Review to Glenveigh Medical's Digoxin Immune Fab (DIF)

The US FDA has granted fast track review to Glenveigh Medical’s Digoxin Immune Fab (DIF), which is being developed as severe preeclampsia therapy.

 

Glenveigh Medical founder and chairman Dr. David Adair said DIF is taking treatment to a level that hasn't been available before for women with severe preeclampsia.

 

"In particular, for women at an early gestation, DIF can potentially stabilize their condition, as well as improve fetal and neonatal outcomes," Dr. Adair added.

 

"These babies have very high death rates and, when they do survive, have increased risks of significant adverse neurological and learning difficulties. Anything that could positively impact this perinatal period would translate into huge gains for society's most fragile citizens."

 

Based on Dr. Adair's research on preeclampsia, the life science and technology based company received orphan drug designation for DIF from the FDA earlier in 2012.

Source: http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-fast-track-review-to-glenveigh-digoxin-immune-fab-131112
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FDA Grants Fast Track Review to Glenveigh Digoxin Immune Fab