Speeding up development of Ebola treatments and vaccines

News 20/10/2014

EMA encourages companies to apply for orphan designation

The European Medicines Agency (EMA) encourages developers of treatments or vaccines against Ebola to apply for orphan designation. Medicines with recognised orphan status have access to a range of incentives to stimulate development and facilitate placing on the market. This includes free scientific advice from EMA, fee waivers and 10 years of market exclusivity once the medicine is authorised.

Applications for orphan designation of Ebola medicines will be treated as a priority and EMA has committed to fast-tracking their evaluation.

Orphan designation provides a regulatory framework to facilitate dialogue between EMA and the developers of a medicine, from the early stages of development. Early and regular interaction with EMA can significantly speed up the development of medicines.

Developers of possible Ebola medicines interested in orphan designation can send an email to orphandrugs@ema.europa.eu to request free pre-submission guidance for orphan designation and to discuss the scientific and regulatory steps.

EMA has been collaborating very closely with the United States Food and Drug Administration (FDA) on orphan medicines over many years. Developers of Ebola medicines are encouraged to submit applications for orphan designation to EMA and FDA in parallel to help speed up the development process for these medicines globally. Both Agencies will be sharing information on the applications received and their assessment to facilitate understanding of data requirements for the relevant applications.

Orphan designation can be granted for medicines under development that are intended for the prevention or treatment of life-threatening conditions affecting no more than 5 in 10,000 people in the European Union, as is the case for Ebola.

EMA's initiatives in the Ebola outbreak

The current outbreak of Ebola virus is a serious public health concern worldwide. At the moment, there are no approved medicines to protect from or treat Ebola. Medicines against this disease are still at an early stage of development. Some experimental treatments against Ebola have reportedly shown encouraging results in the laboratory or in animals, but they have not yet been fully studied in people.

EMA is working together with regulatory authorities around the world to support the World Health Organization and to advise on possible pathways for the development, evaluation and approval of medicines to fight Ebola.

The Agency has established a group of European experts who have specialised knowledge in vaccines, infectious diseases and clinical trial design to contribute to the global response against Ebola. This group also gives advice on scientific and regulatory aspects to individual developers of Ebola medicines.

As part of EMA's overall contribution to the global response to the Ebola outbreak in West Africa, the Agency has started to review available information on Ebola treatments currently under development. The goal is to provide an overview of the current state of knowledge about the various experimental medicines to support decision-making by health authorities. Companies developing promising treatments were invited to send all available quality, preclinical and clinical data about their treatments under development for a review, which is now ongoing.

All companies that are part of this review will be encouraged to submit orphan designation applications for their medicines.

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