International- Regulators discuss accelerated approvals, Project Orbis at DIA

Regulators from the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada gave their perspectives on different issues related to accelerated approval pathways in their respective jurisdictions at the Drug Industry Association’s (DIA) Global Annual Meeting.

All three regulators offer their own form of accelerated approval based on less comprehensive clinical data than a traditional marketing approval would require. In the US, that pathway is dubbed accelerated approval (AA), while the EU version is called conditional marketing authorization (CMA) and in Canada it is referred to as notice of compliance with conditions (NOC/c).

In each case, products approved via these pathways are required to comply with certain postmarketing requirements to maintain approval, such as conducting confirmatory studies to demonstrate benefit.

Julie Lepin, vice president, regulatory affairs, oncology at Amgen, who moderated the session, pointed out that in 2019, the number of new drugs approved based on surrogate endpoints was similar across the three regions, with eight approvals in the US, seven in the EU and six in Canada.

When asked about the ability of regulators to withdraw approval after granting accelerated approval, the three regulators explained their respective approach to withdrawing a product from the market.

Kelly Robinson, director of Health Canada’s Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics, said there are mechanisms for the agency to withdraw a product if efficacy is not demonstrated following a NOC/c…