Dec 22 (Reuters) – The U.S. on Wednesday authorized Pfizer Inc’s (PFE.N) oral antiviral COVID-19 pill for at-risk peopleaged 12 and above, making it the first at-home treatment for the coronavirus and a potentially important tool in the fight against the fast spreading Omicron variant.
Data from Pfizer’s clinical trial showed its antiviral regimen, Paxlovid, was 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.
“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 U.S. Food and Drug Administration’s Center for Drug Evaluation and Research, said.
Pfizer said it was ready to start immediate delivery in the U.S. of the treatment – whose two drug regimen includes a new medicine and a second older antiviral called ritonavir – and raised its 2022 production projections to 120 million courses of treatment from 80 million.