Rasi: EMA may conditionally authorize remdesivir in the ‘coming days’

Regulatory NewsRegulatory News | 18 May 2020 |  By 

The European Medicines Agency’s (EMA) Executive Director Guido Rasi on Monday told a European Parliament committee that the agency could grant conditional marketing authorization to Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) in a matter of days.
“It might be that a conditional marketing authorization can be issued in the coming days, subject to the data that has been submitted,” Rasi said, adding that he does not believe the drug is ready to receive a standard marketing authorization at this stage.
Rasi’s remarks come after EMA initiated a rolling review or remdesivir earlier this month and a week after the agency recommended wider compassionate use of the drug. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus 1 May 2020; Remdesivir: EMA recommends wider compassionate use, Regulatory Focus 11 May 2020).
In the EU, conditional marketing authorizations can be granted before more comprehensive data are available for a drug when there is a positive benefit-risk profile and the product fulfills an unmet medical need. Conditional marketing authorizations are valid for one year but can be renewed before being converted to standard marketing authorizations when more comprehensive data are available. (RELATED: EMA reflects on its first decade of conditional marketing authorizations, Regulatory Focus 24 January 2017).
Conditional marketing authorization is similar to the US Food and Drug Administration’s accelerated approval pathway, which allows the agency to approve products that treat serious or life-threatening conditions based on surrogate or intermediate clinical endpoints that are reasonably likely to predict clinical benefit.
European Parliament


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