EMA reviewing application for Gilead’s remdesivir

Regulatory NewsRegulatory News | 08 June 2020 |  By 

The European Medicines Agency (EMA) on Monday said it has received a conditional marketing authorization application for Gilead Sciences’ remdesivir to treat coronavirus disease (COVID-19) that could receive an opinion in a matter of weeks.
“The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks depending on the robustness of the data submitted and whether further information is required to support the evaluation,” EMA writes.
If the application is recommended for authorization, EMA says it will work with the European Commission to fast-track the process of granting a marketing authorization for the drug.
EMA says its scientific committees and working parties have already assessed quality and manufacturing data as well as preliminary clinical and supporting data as part of the rolling review. The agency also says its Pharmacovigilance Risk Assessment Committee has done an initial assessment of Gilead’s proposed risk management plan for the drug and that the agency has signed off on the company’s pediatric investigation plan.
The announcement comes more than a month after the agency began a rolling review of the drug and follows the US Food and Drug Administration’s (FDA) move to authorize the drug for emergency use in early May. (RELATED: EMA kicks off rolling review of Gilead’s remdesivir, Regulatory Focus 1 May 2020; FDA authorizes Gilead’s remdesivir for emergency use, Regulatory Focus 1 May 2020).


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