FDA clears Pfizer pill as first home COVID treatment in US
The Food and Drug Administration has authorized a new pill from Pfizer that the company says cuts the risk of hospitalization and death in coronavirus patients by 89 percent.
The drug, Paxlovid, received an emergency use authorization for use in patients 12 years old and up who have tested positive for COVID-19 and are at high risk, the FDA said Wednesday.
Paxlovid will be administered alongside a widely used HIV drug. A study of 1,200 patients released last month showed that the drug eliminates nearly nine out of 10 hospitalizations for coronavirus patients.
The prescription-only treatment should be administered as soon as possible after patients are diagnosed with COVID and within five days of the onset of symptoms, the FDA said.
Tens of thousands of the pills will ship in the US before the end of 2021 and hundreds of thousands more are expected at the beginning of 2022, a Pfizer spokesperson told the Wall Street Journal. The US government is paying Pfizer $5.3 billion for 10 million treatment courses that will be delivered by the end of next year, according to the paper.
In a Wednesday statement, the White House said, “We will have over 250,000 treatment courses available to us in January and we will be working with states to ensure those are being distributed equitably and fairly and that our hardest-hit communities are reached.”
Another drugmaker, Merck, also says it has developed a pill that reduces hospitalization and death in coronavirus patients. That pill has not yet received approval from the FDA but is expected to get the go-ahead within days, Bloomberg News reported.
The news comes as the Omicron coronavirus variant surges in New York and across the US, disrupting return-to-office and travel plans. Initial studies suggest that Omicron is more transmissible but less deadly than earlier versions of the virus.
