Jury Still Out on Potential Ebola Treatments, EMA Says

Megan Brooks

December 17, 2014

The jury is still out on the safety or efficacy of experimental therapies for Ebola virus disease, for now, the European Medicines Agency (EMA) said in the first interim report on the subject, released December 16.

"Treatments for patients infected with the Ebola virus are still in early stages of development," Marco Cavaleri, PhD, head of Anti-infectives and Vaccines at the EMA, said in a statement.

"We encourage developers to generate more information on the use of these medicines in the treatment of Ebola patients. We will review any new information as soon as it becomes available to support the response to this ongoing public health crisis," Dr Cavaleri added.

The review of Ebola treatments was initiated by the EMA Committee for Medicinal Products for Human Use to support decision-making by health authorities, the statement explains. The first interim report includes information on seven experimental drugs in development:

  • BCX4430 (Biocryst),

  • Brincidofovir (Chimerix),

  • Favipiravir (Fujifilm Corporation/Toyama),

  • TKM-100802 (Tekmira),

  • AVI-7537 (Sarepta),

  • ZMapp (Leafbio Inc), and

  • Anti-Ebola F(ab')2 (Fab'entech).

The amount of data available for these seven treatments is "highly variable," the EMA says.

For some of these compounds, there are currently no data available in humans. To date, only a "small number" of treatments have been given on a compassionate use means to patients in the current Ebola outbreak. Some medicines included in this first review have already been studied in humans, albeit for the treatment of other viral diseases, the EMA says.

Their interim review does not include vaccines to protect people against contracting the disease and treatments that do not directly target the Ebola virus. There currently are no approved drugs to protect people from Ebola or to treat those infected.

The "scale and complexity" of the current Ebola outbreak requires an "unprecedented" level of cooperation of the international health community, the EMA says. The agency is working with other regulatory agencies around the world to support the World Health Organization and to advise on pathways for the development, evaluation, and approval of Ebola treatments.

The EMA says it will continue to review all Ebola treatments under development and will add new information to this review as it becomes available.

The EMA has established a group of European experts with knowledge in vaccines, infectious diseases, and clinical trial design to contribute to the global response against Ebola. The group will also provide advice to individual developers of Ebola medicines on scientific and regulatory matters. The EMA has created an accelerated scientific advice procedure for developers of Ebola medicines and vaccines.

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