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CHMP Recommends EU Authorization of Remdesivir for COVID-19
The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.
According to a June 25, 2020 press release, CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data, and supporting safety data from compassionate use programs of remdesivir since April 30, 2020. All of this information has been provided in advance of the submission of the marketing authorization application (June 5, 2020) and has been implemented into a rolling review procedure, which has been adopted by EMA in light of the current pandemic situation.
The majority of the information that CHMP used to make its decision came from the NIAID-ACTT-1 study, which demonstrated an improvement in recovery rate for patients with advanced COVID-19, compared with placebo. The EC will now fast-track its decision on the conditional marketing authorization for remdesivir, which is expected in the next seven days.
Gilead Sciences (developer of Veklury) will be required to submit final reports of the remdesivir studies to EMA by December 2020 so that the drug’s efficacy and safety can be better characterized.
Source: EMA