Experimental drugs under EMA scrutiny
30.09.2014 - In the face of the Ebola outbreak sweeping the West African countries, the EMA has started to review investigational treatments for the deadly virus disease.
With 2,600 people dead and the infection rate gathering speed, the current Ebola outbreak represents the widest geographical spread of the disease ever reported. Although there is currently neither vaccine nor cure available, there are several drugs under development. In desperation, local health authorities have already used these experimental compounds to treat patients, in the hope that they might prove effective.
In an effort to support medical staff on-site, the European Medicines Agency is now starting an investigation of these early stage drugs. “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,” explains Guido Rasi, Executive Director of the EMA. “I have therefore asked the EMA Committee for Medicinal Products for Human Use, CHMP, to scrutinise 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 EMA has now called together a group of specialists from all over Europe – experts in vaccines, infectious diseases and clinical trial design. The group has contacted companies known to be developing potential treatments, among them French immunotherapy specialist Fab'entech and US companies Biocryst and Sarepta. Companies that have not yet been contacted are invited to send available data about their treatments under development to the EMA for a review. Meanwhile, human trials for Glaxosmithkline's Ebola vaccine are being put on the fast track with the help of an international consortium.