The EU medicines watchdog approved Pfizer's coronavirus pill on Thursday, making it the first oral antiviral treatment for the disease to be authorized in Europe.
Studies have shown that the drug called Paxlovid reduces hospitalizations and deaths in patients at risk of severe COVID and may also be effective against the Omicron variant.
The pills are seen as a potentially important step in ending the pandemic because they can be taken at home rather than in hospital.
"Paxlovid is the first recommended oral antiviral drug in the EU to treat COVID-19," the European Medicines Agency (EMA) said in a statement.
The United States, Canada and Israel are among a handful of countries that have already given the green light to Pfizer's treatment.
The European Commission must now formally authorize the drug, but it is an approval procedure that usually takes hours or days.
"Paxlovid is the first oral antiviral for home use in our pipeline and has the potential to make a real difference for people at high risk of progression to severe COVID," EU Health Commissioner Stella Kyriakides said in a statement.
"We also saw promising evidence for the effectiveness of Paxlovid against Omicron and other variants."
Pfizer's treatment is a combination of a new molecule, PF-07321332, and the HIV antiviral ritonavir, which are taken as separate tablets.
The EMA said it "recommends authorizing Paxlovid for the treatment of COVID-19 in adults who do not need supplemental oxygen and who are at increased risk of the disease becoming severe."
EMA experts reviewed a study that "shows that Paxlovid treatment significantly reduced hospitalizations or deaths in patients with at least one underlying condition that put them at risk of severe COVID-19."
Patients received the pill within five days of symptom onset, and over the following month only 0.8% of the 1,039 people studied ended up in hospital, compared with 6.3% of those who received a pill. placebo.
There were no deaths in the Paxlovid group and nine deaths in the placebo group, the EMA said.
In December, the EMA allowed states to decide whether to use Paxlovid in an emergency, but delayed a decision on full authorization in the 27-country bloc.
The watchdog is still evaluating a similar application for the anti-COVID pill from US drugmaker Merck.
Unlike vaccines, Pfizer Processing does not target the constantly evolving spike protein that the coronavirus uses to invade cells.
Therefore, in theory, it should be more resistant to variants, and the company said that preliminary laboratory studies have confirmed this hypothesis.
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© 2022 AFP
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