EMA Cautions on Experimental Ebola Treatments in Early Stage Development

December 15, 2014
Pharmaceutical Technology Editors

The agency emphasizes the need for robust scientific assessment and more information on safety and efficacy profiles of Ebola therapies in development.

As EMA continues to review all Ebola treatments currently under development, the agency has highlighted in an interim report, that there is not enough evidence to make conclusions regarding the safety and efficacy of any of the experimental drug candidates for Ebola virus disease.

Any new information that becomes available will be added to the review to provide the best possible overview of data on medicinal treatments for Ebola, stated the press release.

Marco Cavaleri, head of the agency’s anti-infectives and vaccines division, noted that treatments for patients infected with the disease are still in early stages of development and encouraged drugmakers to generate more information on the use of these medicines. “We will review any new information as soon as it becomes available to support the response to this ongoing public health crisis,” he said in a press statement.

The review was started by EMA’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 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).

According to the agency, the amount of information available for the seven treatments is highly variable. For some compounds there is 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. 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.

EMA 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: EMA