The Food and Drug Administration on Wednesday issued an emergency use authorization to allow Pfizer’s antiviral pill to be used to treat COVID-19 at home.
The FDA said in a news release that the drug, named Paxlovid, has been approved for “the treatment of mild-to-moderate” COVID-19 patients.
The drug can be given to anyone over the age of 12 who weighs at least 88 pounds, according to the FDA.
The drug can be given to people “who are at high risk for progression to severe COVID-19, including hospitalization or death,” the FDA said.
The FDA said 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.”
That could be a real-world concern, ABC noted, because to get the drug, patients need access to testing to get a positive test and then need an appointment with a doctor very quickly to get a prescription.
The new drug is most effective “before a person becomes critically ill,” said Dr. Paul Currier, director of the Respiratory Acute Care Unit at Massachusetts General Hospital.
“Once a patient becomes critically ill, the virus has already caused a lot of inflammation in the body that likely cannot be stopped by medicines that only target the virus itself,” he said.
However, the FDA said the emergency authorization was still a step forward.
“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, director of the FDA’s Center for Drug Evaluation and Research, 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,” Cavazzoni said.
The FDA said the drug will not prevent someone from getting COVID-19.
The FDA explained that the drug is a combination of two drugs. “Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein to stop the virus from replicating, and ritonavir, which slows down nirmatrelvir’s breakdown to help it remain in the body for a longer period at higher concentrations,” the FDA said.
The daily dosage consists of three tablets taken at once twice a day for five days.
In its release, the FDA said possible side effects with the Pfizer drug include “impaired sense of taste, diarrhea, high blood pressure and muscle aches.”
The FDA said that anyone who takes the drug and takes other medicines should be aware that drug interactions it called “potentially significant.” It also said there is a caution against those with liver or kidney problems using the drug.
Last week, Pfizer said the drug provided an 89 percent reduction in the risk of hospitalization among high-risk adults, according to Axios.
Among adults not at high risk, there was a 70 percent reduction in hospitalizations, according to Pfizer.
The federal government has already ordered enough of the drug to treat 10 million people at $530 a course. About 250,000 full treatment doses will be available next month.
Pfizer chairman and CEO Albert Bourla called the EUA a “tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world.”
“This breakthrough therapy … will change the way we treat COVID-19 and hopefully help reduce some of the significant pressures facing our health care and hospital systems,” he said.
The FDA is also considering a drug made by Merck and Ridgeback Biotherapeutics’ known as molnupiravir. That drug has only shown a 30 percent reduction in the risk of hospitalization and death.
France, which had orders in for both companies’ drugs, has canceled its order for the Merck pill, according to Reuters.
“The latest studies weren’t good,” Olivier Veran, the health minister for France, said.
Truth and Accuracy
We are committed to truth and accuracy in all of our journalism. Read our editorial standards.