The European Commission has granted a conditional marketing authorization for Remdesivir, the first EU-approved medicine to treat COVID 19.
Approval about accelerated procedure follows a recommendation from the European Medicines Agency (EMA). Protecting public health is a key priority for the Commission and data on Remdesivir have been assessed in an extremely short period of time as part of an ongoing review process, an approach taken by the EMA during public health crisis emergencies to assess data as soon as it becomes available.
This allowed for the rapid issuance of approvals within a week of the EMA's recommendation, compared to an average of 67 days.
Stella Kyriakides, Commissioner for Health and Food Safety, said: Today’s approval of the first drug to treat COVID 19 is an important step in the fight against the virus. We issued the approval less than a month after the request, which clearly shows the EU's determination to respond quickly as soon as new therapies become available. We strive to provide an effective drug or vaccine against coronavirus.
Remdesivir is now conditionally authorized for placing on the market as part of an EU regulatory mechanism set up to facilitate early access to medicines that meet medical needs, including in emergencies in response to public health threats such as the current pandemic.