EMA could approve Gilead’s streamlined remdesivir application for COVID-19 “within weeks”
pharmafile | June 9, 2020 | News story | Manufacturing and Production, Sales and Marketing | COVID-19, EU, Gilead, coronavirus, remdesivir
The European Medicines Agency has received the application from Gilead for the first conditional marketing authorisation (CMA) of its antiviral drug remdesivir in the treatment of COVID-19, it has been revealed, with the agency looking to streamline its review process to approve the therapy for use as soon as possible.
Remdesivir has so far gained perhaps the most traction in the treatment of COVID-19 compared to other therapies, having been shown to reduce recovery times for affected patients in a number of studies. The drug has also been approved for emergency use in this indication in the US, India and South Korea.
The EMA has actually already been evaluating the drug’s benefit/risk profile as part of a rolling review it launched on 30 April and which ran until 15 May. This meant that scientific committees involved were able to assess submitted data and materials at a much faster pace when compared to standard evaluations.
This rolling review included assessments made on issues of quality and manufacturing by the EMA’s Committee for Medicinal Products for Human Use (CHMP), with the group requesting additional data from Gilead in addition to the newly received CMA. The agency’s Pharmacovigilance Risk Assessment Committee (PRAC) also reviewed the risk management plan put forward by Gilead and will continue to evaluate available data to build a safety profile for the drug in routine use.
As a result, the agency has said that it could issue an opinion on the drug’s approval “within weeks”, subject to whether a green light can be given off the back of data amassed so far, or whether additional data will be necessary to make a final call. If all goes well, the EMA said it would push for “fast-tracking of the decision-making process and granting of a marketing authorisation from the European Commission valid in all EU and EEA Member States”.
Matt Fellows
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