FDA nod for first oral antiviral COVID-19 treatment

On Wednesday, the US Food and Drug Administration issued an emergency use authorization (EUA) for pharma giant Pfizer’s (NYSE: PFE) Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19).

Paxlovid is the first oral antiviral to pass FDA inspection and is cleared for use in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Paxlovid is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

"This breakthrough therapy, which has been shown to significantly reduce hospitalisations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems," commented Pfizer chief executive Albert Bourla.