Pfizer Inc said on Wednesday the U.S. Food and Drug Administration authorized 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 percent 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.
The agency said it authorized 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 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 U.S. and raised its production projections to 120 million courses of treatment from 80 million in 2022.
The U.S. government's contract for 10 million courses of the Pfizer drug is priced at $530 per course.
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The Pfizer pills, taken with the older antiviral drug ritonavir, will be sold under the brand name Paxlovid. The pills are meant to be taken every 12 hours for five days beginning shortly after the onset of symptoms.
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 percent.