EMA nod for Pfizer’s oral medication to treat Covid-19
The human medicines committee of the European Medicines Agency (EMA) has recommended granting a conditional marketing authorisation for Pfizer’s oral antiviral medicine Paxlovid for the treatment of Covid-19, the agency said on January 27.
The committee 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, the EMA said.
Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating Covid-19.
In reaching its conclusion, the human medicines committee evaluated data from a study involving patients with Covid-19 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-19.
The analysis was done in patients who received Paxlovid or placebo (dummy treatment) within five days after Covid-19 symptoms began and who did not receive, nor were expected to receive, treatment with antibodies.
Over the month following treatment, 0.8 per cent (eight out of 1039) of the patients receiving Paxlovid were hospitalised for longer than 24 hours, compared with 6.3 per cent (66 out of 1046) of those who received a placebo.
There were no deaths in the Paxlovid group and nine deaths in the placebo group.
Most of the patients in the study were infected with the Delta variant, the EMA said.
“Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants.”
The EMA said that the safety profile of Paxlovid was favourable and side effects were generally mild.
However, ritonavir, a component, is known to affect the action of many other medicines, and warnings and advice have been included in Paxlovid’s product information.
In addition, the company has provided a drug interaction tool on its website which can be accessed through a QR code included in the product information and on the outer carton.
A letter will be sent to relevant healthcare professionals’ organisations to further remind them of the issue, the EMA said.
The human medicines committee concluded that the medicine’s benefits are greater than its risks for the approved use and will now send its recommendations to the European Commission for a rapid decision applicable in all EU member states, the agency said.
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