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The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.
EMA announced on Oct. 30, 2020 has published clinical data supporting the marketing authorization application for Veklury (remdesivir) and a list of COVID-19 medicines and vaccines that have received scientific advice or informal guidance from the agency’s pandemic Task Force. The agency is releasing this information as part of its dedication to transparency of its activities in relation to COVID-19 vaccines and treatments.
There are 64 documents available on EMA’s clinical data website that give a clinical overview, summaries, and the final reports from pharmacokinetic and Phase I clinical studies. Interim study reports from Phase III clinical studies, clinical data from the compassionate use program, and the data anonymization report are also available.
“The publication of clinical data for Veklury is in line with EMA’s landmark policy to proactively publish clinical data supporting marketing authorization applications. The agency had to suspend the publication of clinical data at the end of 2018 as a result of its move from London to Amsterdam. It currently remains suspended due to ongoing business continuity linked to the COVID-19 pandemic and human resource constraints. EMA has decided to exceptionally publish clinical data for COVID-19 medicines given the unprecedented public interest for this information in the context of the ongoing pandemic,” EMA stated in a press release.
Information on the medicines that received scientific advice or guidance includes the stage of development in which the advice was given to help the developer prepare for a marketing authorization application. This advice may include “best methods and study designs for generating robust data on a medicine’s safety and effectiveness. It can also focus on quality aspects, such as manufacturing and testing, or on laboratory studies,” according to EMA.