Chattanooga-made drug on FDA fast track

Chattanooga-made drug on FDA fast track

November 29th, 2012 by Joan Garrett McClane in Business Around the Region

Dr. David Adair talks about an ultrasound of a Tullahoma, Tenn., patient while demonstrating the capabilities of a new telehealth project. The technology makes it possible for doctors in Chattanooga and Knoxville to consult with doctors in more remote locations and offer better care for high risk pregnancies.

Photo by Contributed Photo/Times Free Press.

A drug being made in Chattanooga that is intended to treat severe preeclampsia in pregnant women has been fast tracked by the U.S. Food and Drug Administration, officials said.

"Anything that could positively impact this perinatal period would translate into huge gains for society's most fragile citizens," said Dr. David Adair, founder and chairman of Glenveigh Medical.

Digoxin Immune Fab is being developed by the privately held life science and technology company Glenveigh Medical. It was selected for fast track review because there are no current therapies for preeclampsia, and the federal agency wanted to expedite its development so it potentially could reach consumers faster.

Currently, there are only medications to treat the symptoms of preeclampsia, not the underlying causes of the disease, a statement from Chattanooga-based Glenveigh Medical said.

Preeclampsia, a hypertensive disorder of pregnancy, affects up to 320,000 women annually in the United States and is the leading cause of death among pregnant women. It also triggers early delivery, which can harm the health of the baby and cause neurological damage and learning challenges.

Adair started researching preeclampsia two decades ago because of the need for a medical solution. Earlier this year Glenveigh received orphan drug designation from the FDA for DIF because it was meant to treat a rare condition for which treatment wasn't available.

Future studies of DIF could involve 30 sites across the country, officials said.

"We certainly understand there's an unmet medical need for preeclampsia and eclampsia treatment," said Eleni Tsigas, executive director of the Preeclampsia Foundation, in a statement.

"The fast track designation is significant for expediting Glenveigh's research and development work to help determine if this could be a safe and effective therapy for this dangerous disorder," she said.