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.’
EMA recommends authorising the oral antiviral #Paxlovid for treating #COVID19 in adults who do not require supplemental oxygen and who are at increased risk of severe disease.— EU Medicines Agency (@EMA_News) January 27, 2022