Ebola Virus: Cooperation Of Global Regulatory Agencies
On September 26th, the European Medicines Agency (EMA) announces that the regulatory agency will review experimental medicines to support treatment decisions for the Ebola Virus outbreak in West Africa. Currently there are no approved drugs to protect from or to treat the Ebola Virus and most are only in the early stages of development.
Professor Guido Rasi, the EMA Executive Director, says that:
“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. 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.”
Companies, who are currently developing treatments to treat people infected with the Ebola Virus, are invited to send all available quality, preclinical, and clinical data to the EMA to review. Vaccines to protect people against getting the Ebola Virus and blood therapies involving the use of blood of survivors of the Ebola Virus, are not included in this review process. The following chart identifies companies so far:
6 Companies EMA Will Review For Treatments For Ebola Virus
|Sponsor Company||Product Name|
|Biocryst Pharmaceuticals (US)||BCX 4430|
|Fab’entech (France)||Hyperimmune horse sera|
|MAPP Biopharmaceutical (US)||ZMAPP|
|Sarepta Therapeutics (US)||AVI-7537|
|Toyama Chemicals, Fujifilm Group (Japan) + MediVector Inc (US)||Favipiravir|
14 global regulatory agencies and the EMA recently formed the International Coalition of Medicines Regulatory Authorities (ICMRA). The group met in August 2014 and pledged cooperation for developing medicines to counter the Ebola Virus outbreak.
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