Regulatory News

Europe Establishes Roadmap for Companies Hoping to Get Ebola Treatments Approved

The European Medicines Agency (EMA)—Europe's equivalent to the US Food and Drug Administration (FDA)—says it stands ready, willing and able to help accelerate the evaluation of new medicines and vaccines meant to treat a global outbreak of the Ebola virus.

Earlier this week, the agency said it was encouraging companies to apply for orphan designation for their products—a designation intended to accelerate the review of products by allowing companies to access thorough scientific advice from regulators as well as other incentives. The regulator will also fast track all Ebola product applications, ensuring they get evaluated as quickly as possible.

EMA's scientific advice could prove crucial to companies hoping to bring their Ebola treatments and vaccines to market quickly. Because of the difficulties of testing treatments for Ebola—treatments are used alongside different standards of care, are administered in different countries, lack approved comparators and might not be used alongside a placebo treatment—companies and regulators alike will need to grapple with data that is far less desirable than what EMA typically demands.

Data Demands

At issue for companies: Will the data they collect be sufficient for EMA to approve a product?

EMA said it's willing to bend—but not break—when it comes to ensuring that products meet acceptable standards for safety, efficacy and quality. "Companies are expected to put efforts into demonstrating that vaccines and treatments against Ebola actually work and are acceptably safe and of high quality, because we need to be reassured that the benefits of these medicines outweigh their risks,” said Tomas Salmonson, chair of the agency’s Committee for Medicinal Products for Human Use (CHMP). “However, in the current emergency situation we accept that the benefit-risk balance is determined largely by the public health need.”

“We are ready and keen to assess data as soon as companies start submitting them,” EMA Executive Director Guido Rasi said in a statement. “We have put in place regulatory processes that allow the best experts from across Europe to accelerate the assessment of data once we receive them.”

EMA said it has also established a new "rolling review" program just for investigational Ebola treatments intended to allow its experts to "continuously assess incoming data and develop increasingly robust scientific opinions based on the additional data provided during the process."

Data assessed by EMA officials will be shared with healthcare officials around to world to better allow them to make informed decisions about potential treatments, EMA said.

Will Compani

 

es Come Calling?

One of the biggest questions facing EMA, however, is if its efforts will be quick enough to make a difference. Other regulatory authorities, including FDA, have programs which allow medicines to be quickly deployed in emergency situations, including through the use of its Emergency Use Authorization (EUA) program and its review of emergency investigational new drug (IND) applications.

If companies feel they can reach patients more quickly through other regulators or countries, they might choose to forgo EMA's formal review process until the Ebola outbreak has subsided and instead focus their energies (and staff resources) on maximizing the impact of their now-meager resources.

EMA Statements (1) (2)