First oral treatment for COVID-19 approved for use in US

The US Food and Drug Administration (FDA) has authorised the use of an antiviral treatment specifically for COVID-19, designed in pill form by pharmaceutical company Pfizer Inc. (Pfizer). Called Paxlovid, the treatment can be used by both adults and children over 12 at risk of severe COVID-19; the treatment must be initiated within five days of symptom onset.

Paxlovid comprises two different oral drugs – nirmatrelvir and ritonavir. Nirmatrelvir inhibits 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 metabolised in a human body. The treatment regime is three tablets (two nirmatrelvir and one ritonavir) every 12 hours for five days.

In a large clinical trial, Paxlovid was found to reduce hospitalisation or death from COVID-19 by 88%(in those commencing the treatment within five days of symptom onset). According to healthcare professionals, Paxlovid has the potential to prevent illness and preserve health during this pandemic, as well as eliminate the need for lockdowns.

“Today’s authorisation 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,” said Patrizia Cavazzoni, from the FDA’s Center for Drug Evaluation and Research. “This authorisation 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.”

Pfizer has indicated the antiviral treatment should continue to be effective against the newly emerged Omicron variant and currently has 200,000 courses ready to ship immediately. However, manufacturing projections only suggest between 80 million and 120 million courses of the antiviral will be produced in 2022.

The US government has already purchased 10 million courses of Paxlovid.

Category: Features, Pharmaceuticals