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FDA gives go-ahead for partial testing of new Ebola drug


By Steven Ross Johnson
Posted: August 8, 2014 - 2:45 pm ET
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A Vancouver-based pharmaceutical firm says government regulators have eased safety restrictions on its experimental Ebola drug treatment, raising the possibility of its use in those infected with the virus.

Tekmira Pharmaceuticals Corp. announced Thursday that the U.S. Food and Drug Administration had “verbally confirmed” to modify the full clinical hold placed on the company's experimental drug treatment TKM-Ebola to a partial hold, allowing for the drug to potentially be tested in infected human patients but not in healthy volunteers.

"We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients,” said Mark Murray, CEO and president, Tekmira Pharmaceuticals. “We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola.”

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The announcement highlights the ongoing ethical debate over the use of untested, experimental drugs to address the current crisis in West Africa, where the worst outbreak of Ebola ever recorded has killed more than 900 people in Guinea, Sierra Leone, Liberia and Nigeria.

The World Health Organization this week announced plans to hold a panel discussion of medical ethicists next week who will explore the question of whether medicine that has never been tested and shown to be safe in people should be used in the outbreak.

“We are in an unusual situation in this outbreak. We have a disease with a high fatality rate without any proven treatment or vaccine,” said Marie-Paule Kieny, assistant director-general at the WHO, in a statement. "We need to ask the medical ethicists to give us guidance on what the responsible thing to do is.”

The FDA granted Tekmira “fast track” designation in March, a process the agency uses to expedite the review of drugs designed to treat serious health needs that are currently unmet.

In July the agency sent a notice to Tekmira that it was stopping the company's human study of TKM-Ebola, citing the need for additional information about the safety of its use in healthy human test subjects. The drug is being developed under a $140 million contract with the U.S. Defense Department.

TKM-Ebola would be the second experimental drug that could be available for use on Ebola-infected patients. Recently, two infected Americans were treated with the experimental drug ZMapp, produced by San Diego-based Mapp Biopharmaceutical.

Follow Steven Ross Johnson on Twitter: @MHsjohnson


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