18th May 2024
Paxlovid from Pfizer.
Barcelona News Catalonia News Madrid News Main News

EU Medicines Agency authorises Pfizer tablets for treatment of Covid

Latest: Coronavirus in Spain figures (2 Feb)

The European Medicines Agency (EMA) has recommended granting a ‘conditional marketing authorisation for the oral antiviral medicine Paxlovid for the treatment of Covid-19′, it announced on Thursday. Paxlovid is produced by Pfizer.

The EMA recommended authorising Paxlovid for treating Covid-19 in adults ‘who do not require supplemental oxygen and who are at increased risk of the disease becoming severe’.

Paxlovid will be the first antiviral medicine to be given by mouth that is recommended in the EU for treating Covid.

In reaching its conclusion, the EMA evaluated data from a study involving patients with Covid showing that treatment with Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition, putting them at risk of severe Covid.

The analysis was done in patients who received Paxlovid or placebo (a dummy treatment) within five days after Covid symptoms began and ‘who did not receive, nor were expected to receive, treatment with antibodies’. Over the month following treatment, 0.8% (8 out of 1,039) of the patients receiving Paxlovid were hospitalised for longer than 24 hours, compared with 6.3% (66 out of 1,046) of those who received placebo. There were no deaths in the Paxlovid group and nine deaths in the placebo group.

The majority of patients in the study were infected with the Delta variant. The EMA has said that based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants.

A statement went on to add that ‘the European Commission will now fast-track the decision-making process to grant a decision on the conditional marketing authorisation for Paxlovid, allowing this medicine to be marketed across the EU’. It said: ‘Conditional marketing authorisation (CMA) is used as the fast-track authorisation procedure to speed up approval of medicines during public health emergencies in the EU.’

Click here to read the EMA’s full report.

Sign up for the FREE Weekly Newsletter from Spain in English.

Please support Spain in English with a donation.

Click here to get your business activity or services listed on our DIRECTORY.

Click here for further details on how to ADVERTISE with us.

Recent Posts

Three Spanish tourists killed by gunmen in Afghanistan’s Bamyan province

News Desk

Pedro Sánchez: socialist win in Catalonia ‘ends decade of division and resentment’

News Desk

Sale of Vodafone’s Spanish division for up to €5 billion receives green light

News Desk

Catalan amnesty bill back to Spanish Congress after ‘symbolic’ veto in Senate

News Desk

Ukrainian President Zelensky cancels trip to Spain and Portugal

News Desk

Spain warns smaller vessels of orca run-ins near Strait of Gibraltar over summer

News Desk

Leave a Comment