The Faster Clinical Trials Act would create an FDA Center for Clinical Trial Innovation and aims to cut trial costs and enrollment time by at least 30%.
|Articles|December 16, 2014
Ebola Treatments Still Lack Data, Says EMA
There is not enough available evidence yet for any of the experimental therapies for the Ebola virus disease to draw conclusions on their safety or efficacy when used in Ebola patients, according to an interim report published by the European Medicines Agency.
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There is not enough available evidence yet for any of the experimental therapies for the Ebola virus disease to draw conclusions on their safety or efficacy when used in Ebola patients, according to an interim report published by the European Medicines Agency (EMA) that is continuing to review all Ebola treatments currently under development.
“Treatments for patients infected with the Ebola virus are still in early stages of development,” notes Marco Cavaleri, Head of Anti-infectives and Vaccines at EMA. “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.”
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 those 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).
The amount of information available for the seven treatments is highly variable, and for some compounds there is no data from use in human subjects available, the authors noted. A small number of treatments have been administered to patients in the current Ebola outbreak as compassionate use, and 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 were 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, and the Agency is working together with global regulatory authorities to support the World Health Organization and to advise on possible pathways for the development, evaluation and approval of medicines to fight Ebola, EMA stated.
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