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

September 22, 2014 5:09 PM

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

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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