EMA to review experimental medicines for Ebola
To provide an overview to support decision-making by health authorities
The European Medicines Agency (EMA) is to review available information on Ebola treatments currently under development.
The Agency aims to provide an overview of the current state of knowledge about the medicines under development to support decision-making by health authorities.
There are currently no approved medicines to protect from or treat Ebola. Medicines against this disease are still at an early stage of development. Some experimental treatments have reportedly shown encouraging results in the laboratory or in animals, but they have not yet been fully studied in people.
‘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 Professor Guido Rasi, EMA Executive Director.
‘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.’
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
More 5,300 cases of Ebola have been reported in the current outbreak in West Africa and more than 2,600 people have died. This represents the widest geographical spread of the disease ever reported. Over recent weeks infection rates appear to have gathered speed, leading to an almost exponential increase in the number of cases.
The EMA has established a group of European experts with specialised knowledge of vaccines, infectious diseases and clinical trial design to contribute to the global response against Ebola. Over recent weeks they have been contacting developers of potential treatments and inviting them send all available quality, preclinical and clinical data about their treatments to the EMA for a review.
The companies identified so far 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 not included in this list, but which are also developing Ebola treatments are encouraged to contact the EMA.
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.
The Agency says the scale and complexity of this outbreak requires an unprecedented level of international cooperation. It is working 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.
The EMA and 14 other international regulatory authorities have recently formed the International Coalition of Medicines Regulatory Authorities (ICMRA), which has pledged to join their expertise to identify and define regulatory solutions for issues such as appropriate design of clinical trials, emergency access to treatments, manufacturing challenges or systematic collection of safety and efficacy data when experimental treatments are used in individual patients.
The aim of the cooperation is to accelerate development and access to experimental treatments for patients in need during the current outbreak.
It will also help to provide health authorities in countries affected by Ebola with safe and effective medicines, the Agency said.
