EMA Urges Ebola Drug Developers to Apply for Orphan Status
The European Medicines Agency is urging companies developing drugs and vaccines for Ebola to seek orphan designation to hasten the evaluation of applications for products that could help victims of the current outbreak in West Africa.
The call mirrors efforts by the FDA to speed the development of compounds to combat the deadly virus.
Companies developing promising Ebola treatments should send quality, preclinical and clinical data to both the EMA and the FDA so that reviews and concerns regarding data requirements can be conducted in parallel, the EMA says.
The FDA is working directly with sponsors to clarify regulatory and data requirements necessary to move Ebola products forward in development as quickly as possible, says agency spokesman Stephen King.
To date, the FDA has granted orphan designation to two Ebola products: a prophylactic made by Sarepta Therapeutics and a monoclonal antibody by LeafBio.
The EMA has established a group of European experts with specialized knowledge in vaccines, infectious diseases and clinical trial design to give scientific and regulatory advice on Ebola drugs.
evelopers can request free presubmission guidance for orphan designation, and discuss scientific and regulatory steps by contacting the EMA at email@example.com. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.