FDA Leverages Compassionate Use Program to Allow Access to Experimental Ebola Drug

September 22, 2014 5:09 PM

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Canadian biopharmaceutical company Tekmira has announced that the US Food and Drug Administration (FDA) will allow its investigational Ebola drug, TKM-Ebola, to be used by patients under an emergency expanded access program—a stark reversal for the product, which two months ago was subject to a complete clinical hold.

As Regulatory Focus extensively explained in August, developing new treatments for Ebola is a long and arduous process. Because Ebola, a hemorrhagic fever, is very rare and extremely deadly, companies must utilize FDA's Animal Efficacy Rule ("Animal Rule") in order to bring a drug to market.

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