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Pfizer Inc. announced Tuesday that a final analysis shows its experimental antiviral pill Paxlovid sharply reduced hospitalizations and deaths among people at high risk for severe illness.
The latest results, which reinforce an earlier analysis released in November, Pfizer's drug cut hospitalizations and deaths by nearly 90 percent when taken within three to five days of the start of symptoms, the company said, and preliminary lab studies also suggest the pill will hold up against the Omicron variant.
“This news provides further corroboration that our oral antiviral candidate, if authorized or approved, could have a meaningful impact on the lives of many, as the data further support the efficacy of Paxlovid in reducing hospitalization and death and show a substantial decrease in viral load. This underscores the treatment candidate's potential to save the lives of patients around the world,” Pfizer Chairman and CEO Albert Bourla said in a company statement.
“Emerging variants of concern, like Omicron, have exacerbated the need for accessible treatment options for those who contract the virus, and we are confident that, if authorized or approved, this potential treatment could be a critical tool to help quell the pandemic," he added.
Two antiviral pills, Pfizer's and one from Merck, are now under consideration by the U.S. Food and Drug Administration, with decisions on both expected by the end of the year.
The new treatments can't come soon enough: The Omicron variant that is rapidly taking over in South Africa and countries in Europe, has already been detected in 31 U.S. states. Even worse, early research suggests the variant will probably evade many forms of the main treatment physicians have, known as monoclonal antibodies.
Regeneron Pharmaceuticals warned in late November that its monoclonal antibody cocktail could be less potent against Omicron and emphasized its continuing efforts on next-generation drugs that are more likely to work against the variant. A preprint study published Thursday found that omicron could evade antibody cocktails from Regeneron, Eli Lilly and AstraZeneca, which last week received authorization for a monoclonal antibody to prevent COVID-19 in people whose immune systems do not respond to vaccines.
In its Tuesday announcement, Pfizer also had some good news about people who are at low risk for severe COVID: In an early analysis, a second, ongoing study that tested whether Paxlovid eased COVID-19 symptoms faster in people who are not considered high-risk found no benefit for symptom relief. But those who took the pill regimen saw the amount of virus in their bodies plummet and the pill reduced their already low risk of hospitalization and death. That study included those who were vaccinated and had at least one risk factor for severe COVID.
Still, the Pfizer and Merck pills do have some limitations.
The Merck pill, molnupiravir, has raised concerns about its potential to cause mutations — either in the people who take the pill or in the virus itself. Advisers to the Food and Drug Administration narrowly voted in late November to recommend that molnupiravir receive emergency use authorization, but it is likely the drug will carry recommendations that it not be used during pregnancy.
Meanwhile, Pfizer's pill contains a medication, ritonavir, that can interact with many commonly taken medicines, and those risks may need to be managed by physicians and pharmacists.
SOURCE: Washington Post
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