Food and Drug Administration on Thursday Granted full approval of Pfizer The antiviral COVID pill, Paxlovid, is for adults at high risk of severe infection with the virus.

Paxlovid is specifically recommended for the treatment of mild to moderate COVID-19 in adults over 50 years of age and people with Certain medical conditions That puts them at greater risk of ending up in the hospital or dying from Covid.

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This includes those with diabetes, heart disease, cancer, or a weakened immune system.

as many as possible Three quarters of adults In the United States are at risk of severe COVID-19.

“Today’s approval shows that Paxlovid has met the agency’s strict criteria for safety and efficacy, and that it remains an important treatment option for people at high risk of progression to severe COVID-19, including those with prior immunity,” said Dr. Patricia Cavazzoni, director of the Center for Drug Evaluation. and Research of the US Food and Drug Administration in a news release.

The Food and Drug Administration first made Paxlovid available in December 2021 under Emergency use authorization For high-risk individuals ages 12 and over. Under this designation, the FDA quickly approved the treatment based on preliminary clinical trial data.

The recent FDA decision means that there is now extensive clinical data indicating that Paxlovid is safe and effective.

The treatment consists of two drugs: nirmatrelvir, which blocks a key enzyme the Covid virus needs to replicate, and ritonavir, which boosts the first drug’s ability to fight infection.

Both Pfizer and the US Food and Drug Administration view the treatment as an important complementary tool to vaccination that could help high-risk Americans manage their Covid infections and ultimately save lives.

FDA researchers estimated, based on Covid rates in January, that Paxlovid could “save 1,500 lives and avoid 13,000 hospitalizations each week” in the US.

But it is unclear how many people will receive treatment later this year.

About 4 million doses of Paxlovid are available at pharmacies and health care providers nationwide for free, according to the Department of Health and Human Services. In addition, the US government has a stockpile of 9.6 million doses.

Once this stock is depleted, the government expects to shift Paxlovid distribution to the commercial market.

This means that Pfizer will sell Paxlovid directly to health care providers at an undisclosed price from the company. Paxlovid price at approx $530 per course now.

Pfizer, which saw sales of Paxlovid soar to nearly $19 billion in 2022, expects revenue from the drug to drop 58% in 2023.

In March, an independent panel of US Food and Drug Administration (FDA) advisors recommended the treatment based on three Pfizer clinical trials.

One trial examined high-risk adults who were not vaccinated and had no previous infection with Covid.

That trial found that Paxlovid reduced the risk of hospitalization or death by 86% in adults treated within five days of first symptoms, and by 89% in those treated within three days, according to an FDA review of company data.

The review said no significant safety concerns were identified in the trial, although the agency identified 137 drugs that could lead to serious adverse reactions if they interact with Paxlovid.

The most common drugs that have caused safety issues, the FDA said, are immunosuppressants, which are often used to treat HIV and transplant patients.

FDA’s Office of Surveillance and Epidemiology recorded 271 reports of potentially serious adverse events related to drug interactions with Paxlovid, including 147 hospitalizations and six deaths, as of late January.

FDA staff said these events could be avoided by adjusting the dosage of certain medications, increasing patient monitoring and making sure product labels inform prescribers and patients of potential drug interactions.

For some clinicians, another area of ​​concern is the “rebounds” of Paxlovid. That’s when patients receiving treatment see their Covid symptoms return or show positive results shortly after they initially recovered.

Reports of these cases surfaced shortly after Paxlovid first entered the market.

Both President Joe Biden and his former chief medical adviser Dr. Anthony Fauci appeared to have recovered from Covid after consuming the antiviral cocktail but tested positive again shortly after recovery.

An FDA review of Pfizer’s clinical trials found that overall rates of relapse ranged from 10% to 16%, “with no evidence of a higher rate of relapse or mild relapse” in patients who received Paxlovid than in patients who received a placebo.

These results also held regardless of patients’ risk of severe disease, or whether the Omicron variant or an earlier strain of the virus predominated, according to the FDA review.

Correction: In the United States, there are about 4 million doses of Paxlovid available at pharmacies and healthcare providers nationwide. An earlier version of this story misstated the number.


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