EU contemplates adaptive licensing in the face of Ebola threat
- The European Medicines Agency (EMA) is setting up "super fast" advice procedures to support potential Ebola vaccines as they approach submission. This "adaptive licensing" is focused on approval for Ebola-related prevention and treatment therapies.
- The EMA has requested that all companies developing Ebola therapies come forward with concrete information that can be used as part of a comprehensive database on Ebola drug development.
- ZMapp, the cocktail of three humanized monoclonal antibodies against Ebola, has already been used in Spain to treat an Ebola-infected nurse. In fact, there is nothing that prevents use of unapproved treatments for Ebola; however, the EMA is supporting the creation of a formalized framework to support development.
How quickly things change. As recently as July 2013, when the World Health Organization (WHO) published the "Priority Medicines Report for Europe and the World," Ebola was not included on the list. In fact, the WHO has placed Ebola further down on the priority list and disbanded groups that were working on that topic.
Now, governments are playing catch-up as the race to develop Ebola treatments goes on. Thus far, the EMA has requested detailed information from BioCryst Pharmaceuticals, Fab'entech, Mapp Biopharmaceuticals, Sarepta Pharmaceuticals, and MediVector about their therapies-in-development (or already developed) for Ebola. In addition, GSK is also working on an Ebola vaccine which is being factored into the adaptive licensing framework as well, although company spokespeople have said the vaccine will not be available in time to make effective use of it during the current outbreak.
- The Pink Sheet Ebola Threat Prompts EU To Focus On Adaptive Licensing