EMA Anticipates the EC’s Conditional Marketing Authorization for Gilead’s Remdesivir in Coming Week
EMA to Anticipate the EC’s Conditional Marketing Authorization for Gilead’s Remdesivir in Next Week
Shots:
- EMA’s CHMP has recommended conditional marketing authorization to Veklury (remdesivir) for the treatment of COVID-19 in adults and adolescents aged ≥12yrs. with pneumonia who require supplemental oxygen, making it the first treatment to be approved in EU
- EMA expects the EC to grant conditional marketing authorization for remdesivir next week using a fast-track process, allowing the drug to be commercialized across the 27 EU countries
- Gilead must submit final data for remdesivir studies till Dec’2020 and additional data on quality and final mortality data till Aug’2020. The CHMP’s recommendation follows the US FDA’s decision to authorize drug for emergency use last month
Click here to read full press release/ article | Ref: EMA | Image: STAT
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