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The FDA on Wednesday granted emergency use authorization of a new antiviral pill to treat people with symptomatic COVID-19.
Pfizer’s ritonavir (Paxlovid) can now be taken by patients aged 12 and up who weigh at least 88 pounds.
The antiviral is only for people who test positive for coronavirus, and who are at high risk for severe COVID-19, including hospitalization or death. It is available by prescription only and should be taken as soon as possible after diagnosis and within 5 days of the start of symptoms
Paxlovid is taken as three tablets taken together orally twice a day for 5 days, for a total of 30 tablets.
Possible side effects include reduced sense of taste (ageusia), diarrhea, high blood pressure, and muscle aches.
The authorization arrives as the US faces a surge in Omicron case numbers. Evidence points to waning effectiveness of some monoclonal antibody treatments as Americans struggle to maintain some sense of tradition and normalcy around the holidays.
Paxlovid joins remdesivir as available antivirals to treat COVID-19. Remdesivir is fully approved by the FDA but is only given intravenously in the hospital.
The pill form of COVID-19 antivirals come with some obvious advantages — including greater convenience for consumers, including home use, and the potential to expand treatment for people in low- and middle-income countries.
“An Exciting Step Forward”
The emergency use authorization (EUA) for Pfizer’s new drug has been highly anticipated, and news of its impending authorization circulated on social media on Tuesday. Eric Topol, MD, called the development an “exciting step forward.” (Topol is editor-in-chief of Medscape.)
Topol and many others, however, also expected the FDA to grant emergency use authorization for an antiviral from Merck. There was no immediate word Wednesday if that was going to happen.
Looks like Paxlovid (and Molnupiravar) are getting FDA authorized tomorrow. It's an exciting step forward. If you're not familiar with why this is important and the issues surrounding these new anti-Covid pills, here are 2 recent essayshttps://t.co/qClag5KjUy https://t.co/C9oKhFBipw
— Eric Topol (@EricTopol) December 22, 2021
An Accelerated Authorization?
FDA’s authorization for Pfizer’s antiviral comes about 5 weeks after the company submitted an application to the FDA. In its submission, the company said a study showed the pill reduced by 89% the rate of hospitalization and death for people with mild-to-moderate COVID-19 illness.
In April, Pfizer announced its antiviral pill for COVID-19 could be available by year’s end. In September, an official at the National Institutes of Allergy and Infectious Diseases seconded the prediction.
Merck filed its EUA application with the FDA in October. The company included results of its phase 3 study showing the treatment associated with a 50% reduction in COVID-19 hospitalizations.
Interestingly, in September, Merck announced the findings of laboratory studies suggesting that molnupiravir would work against variants of coronavirus because the agent does not target the virus’ spike protein. At the time, Delta was the dominant variant in the US.
The US government has already recognized the potential of these oral therapies, at least in terms of pre-orders.
Last month it announced intentions to purchase $1 billion worth of Merck’s molnupiravir, adding to the $1.2 billion worth of the pills the US ordered in June. Last month, the government announced it would purchase 10 million courses of the Pfizer pill at an estimated cost of $5.3 billion.
The government pre-orders of the antiviral pills for COVID-19 are separate from the orders for COVID-19 vaccines. Yesterday, the Biden Administration announced it will make 500 million tests for coronavirus infection available to Americans for free in early 2022.
FDA: Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19
Damian McNamara is a staff journalist based in Miami. He covers a wide range of medical specialties, including infectious diseases, gastroenterology, and critical care. Follow Damian on Twitter: @MedReporter.
Content Source: https://www.medscape.com/viewarticle/965398?src=rss