The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for Pfizer’s Paxlovid, an oral COVID-19 treatment showing great promise in trials. This will make it the first oral treatment for COVID-19 to be approved in the United States.
The final analysis from the trial showed that the treatment reduces the risk of hospitalization or death in vulnerable adults by almost 90 percent. Early data is encouraging in its effectiveness against the Omicron variant, which is already the dominant strain in the US and is expected to become the dominant variant across Europe in the next few months.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally – a major step forward in the fight against this global pandemic,” Dr Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”
Paxlovid has been authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients aged 12 and up.
It is made of two drugs. One is called nirmatrelvir. Its role is to inhibit the SARS-CoV-2 protein that helps the virus replicate. The second drug is ritonavir. Its role is to slow down the natural breakdown of nirmatrelvir in the body so that the first drug remains active for longer. Each treatment is made up of three pills – two pills of nirmatrelvir and one of ritonavir – and they are taken twice daily for five days, for a total of 30 tablets.