FDA approves Paxlovid to treat COVID-19

LOCAL RESEARCHERS FOUND. >> WE HAVE KNOWN FOR A WHILE THAT THE ANTIVIRAL DRUG CAN DRAMATICALLY REDUCE HOSPITALIZATION OR DEATH FOR THOSE NOT VACCINATED AGAINST COVID. THIS NEW DATA FOCUSES ON WHAT THE DRUG MEANS FOR PEOPLE WHO HAVE GOTTEN THEIR COVER SHOTS AND THEIR SIGNIFICANT BENEFIT. RESEARCHERS AT MASS GENERAL BRIGHAM FOUND TAX LIMIT CAN CUT THE RISK OF HOSPITALIZATION AND DEATH BY NEARLY HALF AMONG THOSE WHO ARE VACCINATED AGAINST COVID. ONE OF THE STUDY AUTHORS SAYS THAT KNOWING THAT PAXLOVID CAN STILL HELP REDUCE HOSPITALIZATIONS, EVEN WHEN MORE PEOPLE ARE VACCINATED IS CRITICAL. >> WE ESTIMATE WE COULD AVOID AT LEAST A QUARTER OF ALL ADMISSIONS TO THE HOSPITAL FOR COVID OVER THIS NEXT WAVE. IF WE CAN DO A BETTER JOB OF GETTING BACK. PARTICULARLY THIS HIGH-RISK MOVE FOR PEOPLE TO MAKE SURE THAT THEY ARE ABLE TO TEST THEMSELVES PROPERLY AT HOME AND LET US KNOW THEY ARE POSITIVE. SO WE CAN PROVIDE THEM THERAPY. >> THAT IS KEY, MAKING SURE PEOPLE ARE TESTING WHEN THEY ARE SICK SO THEY CAN REACH OUT TO THEIR DOCTOR AND SEE IF PAXLOVID IS FOR THEM. THIS IS IMPORTANT FOR ANYONE IN THE HIGH RISK CATEGORY INCLUDING PEOPLE WHO HAVE NOT BEEN BOOSTED. AS FOR REBOUND INFECTIONS THAT WE HAVE HEARD A LOT ABOUT, DR. DRYDEN PETERSON SAYS THOSE ARE LESS SEVERE AND LESS LIKELY TO LAND YOU IN THE HOSPITAL OR WORSE FOR HIGH-RISK PATIENTS HE SAYS THAT STILL MEA

The U.S. Food and Drug Administration on Thursday fully approved the antiviral medication Paxlovid to treat mild-to-moderate COVID-19 in adults at risk for severe infections.Paxlovid had been available for adults and teens in the United States under an emergency use authorization, or EUA, which strictly limited how the medication could be prescribed.The FDA's standards for full approval are stricter than those for an EUA."Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a news release.Full approval will give doctors more leeway in how they use the drug. For example, they may choose to prescribe a longer course if a person shows signs that their infection may coming back, a phenomenon called rebound.The FDA says Paxlovid should only be used to treat COVID-19. It should not be used to as pre-exposure or post-exposure prevention of the infection.Paxlovid is a combination of two medications – nirmatrelvir and ritonavir – which are taken together as pills for five days within the first five days of a person's COVID-19 symptoms.In the clinical trials that led to the medications approval, Paxlovid reduced the risk of hospitalization or death by 86% compared to a placebo in patients at risk for severe disease because of their age or an underlying health condition.The FDA says that Paxlovid is the fourth drug and first pill to be approved for the treatment of COVID-19.It is difficult for some people to take because it has interactions with many other types of medications. For that reason, it will come with a black box warning about its potential to interfere with other drugs.Today's approval only covers treatment for adults, but the FDA says the drug will still be available for adolescents ages 12-18 under emergency use authorization.

The U.S. Food and Drug Administration on Thursday fully approved the antiviral medication Paxlovid to treat mild-to-moderate COVID-19 in adults at risk for severe infections.

Paxlovid had been available for adults and teens in the United States under an emergency use authorization, or EUA, which strictly limited how the medication could be prescribed.

The FDA's standards for full approval are stricter than those for an EUA.

"Today's approval demonstrates that Paxlovid has met the agency's rigorous standards for safety and effectiveness, and that it remains an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity," said Dr. Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, in a news release.

Full approval will give doctors more leeway in how they use the drug. For example, they may choose to prescribe a longer course if a person shows signs that their infection may coming back, a phenomenon called rebound.

The FDA says Paxlovid should only be used to treat COVID-19. It should not be used to as pre-exposure or post-exposure prevention of the infection.

Paxlovid is a combination of two medications – nirmatrelvir and ritonavir – which are taken together as pills for five days within the first five days of a person's COVID-19 symptoms.

In the clinical trials that led to the medications approval, Paxlovid reduced the risk of hospitalization or death by 86% compared to a placebo in patients at risk for severe disease because of their age or an underlying health condition.

The FDA says that Paxlovid is the fourth drug and first pill to be approved for the treatment of COVID-19.

It is difficult for some people to take because it has interactions with many other types of medications. For that reason, it will come with a black box warning about its potential to interfere with other drugs.

Today's approval only covers treatment for adults, but the FDA says the drug will still be available for adolescents ages 12-18 under emergency use authorization.

FDA approves Paxlovid to treat COVID-19

TRACKING THE COVID-19 VACCINE

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