EMA Points to Limited Progress in Advancing Ebola Treatments


From DCAT Value Chain Insights (VCI)

By Regulatory News posted 12-16-2014 11:23

  

The European Medicines Agency (EMA) issued an interim report on Ebola treatments currently under development and concluded that at this point in time there is not enough evidence for any of the experimental therapies for Ebola Virus Disease to draw conclusions on their safety or efficacy when used in Ebola patients.

“Treatments for patients infected with the Ebola virus are still in early stages of development,” said Marco Cavaleri, head of anti-infectives and vaccines at EMA, in an agency statement. “We encourage developersto 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.”

The EMA review was started by the agency’s Committee for Medicinal Products for Human Use (CHMP) to support decision-making by health authorities. This first interim report includes information on seven experimental medicines intended for the treatment of people infected with the Ebola virus: 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).

EMA said that the amount of information available for the seven treatments is highly variable. For some compounds there are no data from use in human subjects available. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use. Finally, there are also medicines included in this review that have already been studied in humans albeit for the treatment of other viral diseases. Vaccines to protect people against contracting the disease and treatments that do not directly target the Ebola virus have not been included in the review.

The review of experimental Ebola treatments is part of EMA’s overall contribution to the global response to the Ebola outbreak in West Africa. The scale and complexity of this outbreak requires an unprecedented level of cooperation of the international health community. The agency is working together with regulatory authorities around the world to support the World Health Organization and to advise on possible pathways for the development, evaluation and approval of medicines to fight Ebola.

Source: European Medicines Agency

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