A pill from Pfizer became the first oral COVID-19 treatment to be authorized by the Food and Drug Administration.
The agency granted the treatment emergency authorization on Dec. 22. It could be available to patients as soon as this weekend, pending approval from the Centers for Disease Control and Prevention.
The medication has been approved for those ages 12 and older with mild to moderate COVID who are considered at high risk of a severe case. This includes those “who are mostly likely to end up hospitalized or not survive,” per CNBC.
The two-drug regimen was found to be 90% effective in preventing hospitalization or death among those in this risk category, according to data from clinical trials.
The FDA said the pill should be prescribed within five days following the onset of symptoms or rapidly after diagnosis.
“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,” according to U.S. News & World Report.
“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” Dr. Patrizia Cavazzoni, the director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “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.”
Pfizer executives said earlier this year that it had already shipped pills to U.S. distributors in preparation for the FDA’s approval. The company currently plans to produce 120 million courses of the treatment during 2022.
The company already has a contract with the United States government for 10 million courses of the pill, priced at $530 per course.
The pharmaceutical company is also seeking approval for its treatment from Canadian health officials, as is competitor Merck. An FDA panel gave selective approval to Merck’s antiviral COVID pill earlier this year but has not granted the treatment an emergency use authorization.
Pfizer plans to file with the FDA for full regulatory approval of its treatment next year.