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FDA lifts hold on experimental Ebola drug

By From page B11 | August 08, 2014

WASHINGTON — U.S. health authorities have eased safety restrictions on an experimental drug to treat Ebola, a move that could clear the way for its use in patients infected with the deadly virus.

Canadian drugmaker Tekmira Pharmaceuticals Corp. said the U.S. Food and Drug Administration modified a hold recently placed on the company’s drug after safety issues emerged in human testing.

The company has a $140 million contract with the U.S. government to develop its drug, TKM-Ebola, which targets the genetic material of Ebola. But last month the FDA halted a small study of the injection in adults to request additional safety information.

Tekmira said Thursday the agency “verbally confirmed” changes to the hold that may allow the company to make the drug available, although it has yet to be proven as safe and effective.

Two Americans diagnosed with Ebola recently received a different experimental drug called ZMapp, made by Mapp Biopharmaceutical Inc. of San Diego. It is aimed at boosting the immune system’s efforts to fight off Ebola and is made from antibodies produced by lab animals exposed to parts of the virus.

 

The Associated Press

The Associated Press

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