Ebola Outbreak Sparks EMA Review of Experimental Ebola Treatments

In response to the Ebola outbreak, EMA has started reviewing Ebola treatments in the development pipeline.

In response to the Ebola outbreak, the European Medicines Agency (EMA) has started reviewing Ebola treatments in the development pipeline. According to the agency, the aim of this move is to provide an overview of the current information available about the various experimental medicines to support decision-making by health authorities.

Several companies have been invited to send all available quality, preclinical, and clinical data about their treatments under development to EMA for a review. The companies identified include:

  • Biocryst, a US-based company developing BCX 4430

  • Fab’entech, from France, developing Hyperimmune horse sera

  • MAPP Biologicals, a US-based company developing ZMAPP

  • Sarepta, a US company developing Sarepta AVI-7537

  • Toyama Chemicals, Fujifilm Group, based in Japan and MediVector Inc, based in the US, who are jointly developing Favipiravir

  • Tekmira, a Canadian company developing TKM-Ebola.

Companies that are not included in the list above but are also developing Ebola treatments are encouraged to contact EMA.

Most drugs targeting the disease are still in early stage development and there are no medicines approved for the treatment of or protection from Ebola to date. Some experimental treatments for Ebola have shown promising results in the laboratory or in animal studies, but none have been tested in humans.

“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,” Professor Guido Rasi, EMA executive director, explained in a press statement. “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 past few weeks have seen infection rates mounting up, leading to an almost exponential increase in the number of cases. Over 5300 Ebola cases have been reported to date, with more than 2600 deaths recorded. The current outbreak represents the widest geographical spread of the disease.

EMA has gathered a group of European experts with specialized knowledge in vaccines, infectious diseases, and clinical trial design to contribute to the global response against Ebola. The group has proactively contacted developers of potential treatments for use in patients over the recent weeks.

The review will focus on medicines under development that are used to treat people infected with the virus. Vaccines to protect people against contracting the disease and blood therapies involving the blood of survivors of Ebola infection are excluded from this review.

Source: EMA