The anti-Covid pill from the manufacturer Pfizer, marketed under the name Paxlovid, was approved on Thursday by the European Medicines Agency (EMA), becoming the first oral antiviral treatment against the disease authorized in the European Union.

"Paxlovid is the first oral antiviral medicine recommended in the EU to treat Covid-19," the EMA said in a statement.

For patients at increased risk

Studies have indicated that it significantly reduces hospitalizations or deaths in patients at risk of developing severe disease, and should remain effective against the Omicron variant. Antivirals work by decreasing the ability of a virus to replicate, thereby curbing disease. This type of tablets could potentially mark a step towards the end of the pandemic because they are easy to administer: they can be taken at home with a glass of water.

The regulator recommended “allowing Paxlovid for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming serious”.

The Pfizer pill is a combination of a new molecule, PF-07321332, and ritonavir, an HIV antiviral, which are taken as separate tablets.

Significant risk reduction

The United States, Canada and Israel are among the handful of countries that have already given the green light to this anti-Covid pill from Pfizer.

EMA experts looked at a study 'showing that treatment with Paxlovid significantly reduced hospitalizations or deaths in patients who had at least one underlying condition that put them at risk of severe Covid-19 ".

The pill was given to patients within five days of the onset of symptoms and over the next month only 0.8% of the 1,039 people studied ended up in hospital, compared to 6.3% of those with received a placebo.

There were no deaths in the group that received Paxlovid and nine deaths in the placebo group, the EMA said.

"The EMA's Committee for Medicinal Products for Human Use has concluded that the drug's benefits outweigh its risks for the approved use" and will "now send its recommendations to the European Commission for a rapid decision applicable in all states members of the EU”.

Merck's pill awaits green light

Approval by the Commission usually takes a few hours to a few days.

"Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progressing to a severe form of Covid", welcomed in a press release the European Commissioner for Health and to Food Security, Stella Kyriakides.

Our file on Pfizer

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The EMA had already approved the emergency use of Paxlovid in December, in support of national authorities, who could decide on a possible early use of the drug.

The regulator is still assessing a similar request for the anti-Covid pill from US drugmaker Merck.

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