FDA authorizes first pill developed specifically to treat COVID-19
The first oral treatment designed specifically for COVID-19 has been authorized for use in the United States by the Food and Drug Administration (FDA). Called Paxlovid, the treatment is currently recommended for those at high risk of severe COVID-19 and is to be taken within five days of symptom onset.
“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,” says Patrizia Cavazzoni, from the FDA’s Center for Drug Evaluation and Research. “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.”
The FDA’s emergency use authorization (EUA) allows treatment with Paxlovid in both adults and children aged 12 and over. The treatment focuses on those at high risk of developing severe COVID-19 and must be initiated within five days of symptoms appearing.
Paxlovid comprises two different oral drugs – nirmatrelvir and ritonavir. Nirmatrelvir is a novel molecule designed to inhibit replication of the SARS-CoV-2 virus and ritonavir is a pre-existing drug used to boost the antiviral capacity of nirmatrelvir by slowing the rate it is metabolized in a human body. The treatment regime is three tablets (two nirmatrelvir and one ritonavir) every 12 hours for five days.
A large clinical trial testing Paxlovid found it reduced hospitalization or death from COVID-19 by 88 percent in those commencing the treatment within five days of symptom onset. There are other trials exploring the use of Paxlovid as a tool to prevent severe COVID-19 in those potentially exposed but yet to turn positive, however, the FDA is clear in noting this authorization is not directed at those uses.
Pfizer, the company developing Paxlovid, has previously indicated the antiviral treatment should continue to be effective against the newly emerged Omicron variant. So this authorization is good news as the world moves into the third year of this pandemic.
But, the big problem now could be one of supply…
The US government has already purchased 10 million courses of Paxlovid. Pfizer says it currently has 200,000 courses ready to ship immediately but manufacturing projections only suggest between 80 million and 120 million courses of the antiviral will be produced in 2022.
In an editorial for The Guardian, Eric Topol, director of the Scripps Research Translational Institute, says Paxlovid has the potential to change the face of the pandemic, if it was made readily accessible everywhere in the world as soon as possible.
“If we had an unlimited supply of these pills, it could have an extraordinary impact on preventing illness, preserving our healthcare workforce, staving off spread, eliminating the need for lockdowns and school closings,” writes Topol. “We must find a way to rapidly scale pill pack production for wide accessibility and use throughout the world, whether that involves enacting the Defense Production Act in the United States or other bold measures. It is not appropriate at this juncture to rely on a single company to mass produce a small molecule which companies throughout the world are fully capable of making with the highest manufacturing standards.”