The U.S. on Wednesday authorized Pfizer Inc's oral antiviral COVID-19 pill for at-risk people aged 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.
The agency's decision comes as the country combats a surge in COVID-19 cases driven by the Omicron variant, with U.S. President Joe Biden announcing plans for more federal vaccination and testing sites.
The U.S. government's contract for 10 million courses of the Pfizer drug is priced at $530 per course.
The agency said it authorized the oral drug for emergency use for the treatment of mild-to-moderate disease in adults and pediatric patients 12 years of age and older, who are at high risk for progression to severe COVID-19.
The drug 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, the agency said. The pills are meant to be taken every 12 hours for five days beginning shortly after the onset of symptoms.
The second drug, ritonavir, is known to have interactions with some other prescription medicines. Pfizer has said that should be manageable and suggested most patients would be able to lower the dose of their other medications while being treated for COVID-19.
Pfizer said it plans to file a new drug application with the FDA in 2022 for potential full regulatory approval.
A rival pill from Merck & Co, which is under review by the FDA, has shown lower efficacy compared with Pfizer's treatment. Merck's drug, molnupiravir, reduced hospitalizations and deaths in its clinical trial of high-risk patients by around 30%.
Pfizer shares were up 2% at $60.18 in afternoon trading on Wednesday.