Pfizer Inc said on Wednesday the US Food and Drug Administration (FDA) has authorised its antiviral COVID-19 pill, making it the first at-home treatment for the coronavirus that is expected to become an important tool in the fight against the fast-spreading Omicron variant.
Data from Pfizer’s clinical trial showed its antiviral regimen was 90% effective in preventing hospitalisations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron.
The agency said it authorised the oral drug for emergency use for the treatment of mild-to-moderate disease in adults and pediatric patients of 12 years of age and older weighing at least 40 kilograms, or about 88 pounds, who are at high risk for progression to severe COVID-19.
“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,” Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
The drug is available by prescription only and should be initiated as soon as possible after the diagnosis of COVID-19 and within five days of symptom onset, the agency said.
The company said it was ready to start immediate delivery in the US and raised its production projections to 120 million courses of treatment from 80 million in 2022.
The US government’s contract for 10 million courses of the Pfizer drug is priced at $530 per course.
