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EMA offers orphan drug benefits for Ebola research

Incentives to encourage development of new treatments for the virus

The European Medicines Agency (EMA) is attempting to speed up the research of new Ebola treatments by encouraging companies to apply for 'orphan drug' designation.

Treatments for Ebola, which continues to affect the West Coast of Africa, qualify as it is a rare disease in Europe, meaning it affects no more than five in 10,000 people in the EU.

Orphan drug designations provide companies with incentives to research treatments that tend to have a poor return on investment compared to drugs for more common conditions. The incentives include free scientific advice from EMA, fee waivers and 10 years of market exclusivity.

The EMA hopes the designation will motivate companies to pursue research in Ebola, which has killed more than 4,500 people in West Africa this year and affected healthcare workers from the US and Europe.

Measures to contain the disease seem to be working in some areas, with the World Health Organization (WHO) stating this week that limited outbreaks were over in both Nigeria and Senegal, although wider epidemics remain in Liberia, Guinea and Sierra Leone.

One treatment - Mapp Pharmaceuticals' ZMapp - is known to have successfully treated some patients with the virus, although stocks are now depleted and the drug remains unapproved by any authority.

The drug was one of several investigational treatments that the EMA last month said it intends to review available information for. Companies that are part of this review are encouraged to submit orphan designation applications for their medicines.

Investigational Ebola treatments under review by the EMA

BCX 4430
Hyperimmune horse sera
Mapp Biologicals
Sarepta AVI-7537
Toyama Chemicals and MediVector

Researchers behind Ebola treatments are encouraged to submit applications for orphan designation to both the EMA and the US FDA as the two agencies intend to share information and expertise.

Several companies, including Johnson & Johnson and GlaxoSmithKline (GSK) are also developing vaccines for the Ebola virus.

In an update published at the end of last week GSK said that vaccine development was progressing at an “unprecedented rate” and that first phase I safety trials were underway in the US, the UK and Mali.

Initial data from these trials is expected by the end of this year and the next phase of the trial programme - involving the vaccination of thousands of frontline healthcare workers in West Africa - is due to begin in early 2015.

NewLink Genetics, another company with a vaccine in development, has said its product is expected to start clinical trials in October.

Article by
Thomas Meek

21st October 2014

From: Research, Regulatory, Healthcare



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