OR WAIT null SECS
The agency recommends that companies developing drugs to treat Ebola apply for orphan drug designation.
The European Medicines Agency (EMA) has stated that it intends to work with global regulatory agencies in assisting the World Health Organization (WHO) to develop, evaluate, and approve drugs to fight the Ebola virus. The agency is establishing a group of experts in the field of vaccines, infectious diseases, and clinical trial design to help in the global fight against the virus.
EMA also plans on reviewing information on Ebola treatments currently under development to assist health authorities with decision-making. The agency is asking that companies with drugs in development send the agency all their quality, preclinical, and clinical data for drugs currently under development.
To assist in the Ebola treatment development process, EMA is encouraging companies to apply for orphan designation for their Ebola treatments or vaccines. Drugs with orphan designation receive access to development incentives including advice from EMA, fee waivers, and 10 years of market exclusivity if the product is given orphan designation. EMA says that applications for orphan designation for Ebola treatments will be treated as a priority. The agency also encourages developers to also apply for orphan drug status in the US at the same time. FDA and EMA will share information on applications and agency assessments.