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EMA to review experimental Ebola drugs

Response comes as death-toll tops 3,000

Drug regulator the European Medicines Agency (EMA) has said it is to review experimental Ebola drugs in the wake of the ongoing outbreak in West Africa.

Since the start of the outbreak in Guinea at the end of 2013 more than 3,000 people have died and more than 5,300 have been infected in Guinea, Liberia, Sierra Leone and Senegal, most in the past three months.

Timeline of Ebola outbreak in West Africa
December 6, 2013Two-year-old child contracts Ebola virus in Guinea
March 19, 2014Guinea's Ministry of Health acknowledges a local outbreak
April 2014Outbreak hits neighbouring Sierre Leone and Liberia
June 2014Médecins Sans Frontières calls for international aid
July 25, 2014First case reported in Nigeria
August 8, 2014Outbreak designated as a public health emergency of international concern by WHO
August 26, 2014Death toll reaches 1,500
August 29, 2014Senegal confirms first case of Ebola virus
September 16, 2014UN calls for $1bn to help fight outbreak
September 26, 2014EMA announces it is to review experimental medicines

The death toll has been exacerbated by the lack of treatment options for Ebola and drugs are desperately needed, with the EMA noting, “there are no approved medicines to protect from or treat Ebola”.

One unapproved drug – MAPP Biologicals' antibody combination ZMapp – has already been used in some care workers affected by Ebola, including British nurse Will Pooley who has now made a full recovery from the disease.

Stocks of ZMapp are now thought to be depleted, although the drug was named by the EMA as one it intends to assess as part of its review.

Other experimental Ebola drugs cited by the EMA include Biocryst's BCX 4430, Fab'entech's Hyperimmune horse sera, Sarepta's AVI-7537, Toyama Chemicals and MediVector's Favipiravir and Tekmira's TKM-Ebola.

“Health authorities or practitioners who need to take a decision whether or not to use an experimental Ebola treatment in a patient are currently lacking independent information,” said Prof Guido Rasi, EMA Executive Director.

“I have therefore asked the EMA Committee for Medicinal Products for Human Use, CHMP, to scrutinize all the available information about experimental treatments and compile everything we know to date about their efficacy, safety and quality. This will facilitate evidence-based decision-making.”

The medicines mentioned will be assessed by a group of European experts who have specialised knowledge in vaccines, infectious diseases and clinical trial design.

The World Health Organizaton (WHO), which is leading the global response to the Ebola outbreak, has previously backed the use of untested drugs, while both GSK and Johnson & Johnson have fast-tracked the development of vaccines for the virus.

Using untested drugs: an ethical dilemma

The rate at which the Ebola virus has spread and the lack of treatments has caused an ethical quandary: should drugs that have not proven their safety in clinical trials be used?

The WHO has decided that the public health risk posed by the Ebola outbreak makes it acceptable to do so, with an expert panel unanimously agreeing that it was ethical to offer “interventions with as yet unknown efficacy and adverse effects, as potential treatment or prevention”.

Leading the way is the experimental drug ZMapp, but it's uncertain if the drug works or is even fully safe to use. Writing in the New England Journal of Medicine former FDA chief scientist Jesse Goodman summed up the dilemma: “In the heat of this moment, we need to think both carefully and humanistically.”

Article by
Thomas Meek

30th September 2014

From: Research, Regulatory, Healthcare



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