FDA Approves First Covid-19 Treatment Pill, Paxlovid. from Pfizer


A view of the Pfizer World Headquarters in Midtown Manhattan, New York City on December 15, 2020. Photo: zz/STRF/STAR MAX/IPx 2020 (AP)

On Wednesday afternoon, the Food and Drug Administration approved the first antiviral pill for the treatment of Covid-19: the treatment Paxlovid developed by Pfizer. In clinical studies, Paxlovid was shown to reduce the risk of serious illness from Covid-19 in high-risk patients shortly after infection by almost 90%.

Paxlovid is a two-drug combination of nirmatrelvir, a new antiviral drug developed by Pfizer designed to prevent the coronavirus from multiplying in cells, and ritonavir, a long-standing antiviral drug used to treat HIV (believed becomes that ritonavir extends the life of nirmatrelvir in the body). It is taken as three tablets twice a day, for no longer than five days, and is intended to be prescribed as soon as possible after a positive Covid-19 test and within five days of the onset of symptoms. It is recommended for people over the age of 12 who have mild to moderate Covid-19, but also have risk factors that predispose them to severe Covid-19.

In the pivotal clinical trial studied by the FDA, involving more than 2,000 people, high-risk patients with mild to moderate Covid-19 who received Paxlovid were 88% less likely to be hospitalized in the following month because of Covid-19 or from any cause than those who received a placebo. Overall, about 0.8% of patients on Paxlovid died or were hospitalized from Covid-19, compared to 6% of the control group.

Since the start of the pandemic, scientists have been looking for treatments that could help treat or prevent the worst effects of Covid-19. A few options have been worked out, such as monoclonal antibodies, but many have not – and even these antibodies require special infusion centers and are difficult to scale up. For this reason, many experts are understandably excited about Paxlovid’s potential.

“Today’s approval introduces the first treatment for Covid-19 in the form of a pill taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and research, in the FDAs Announcement of their authorization for emergency use. “This authorization provides a new tool to fight Covid-19 at a pivotal time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible for patients at high risk of progression to severe Covid-19.”

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Some monoclonal antibodies have now fallen out of favor, with early data show that they are not as effective against the Omicron variant as before (it is believed that Omicron’s mutations make it particularly good at evading antibodies trained to recognize the original coronavirus). However, Pfizer claims their data shows that Paxlovid should remain effective against Omicron and other variants.

Paxlovid is probably not the only antiviral drug soon available for Covid-19. Merck’s treatment molnupiravir is also: expected to be approved by the FDA in days, although the drug has not had as impressive results as Paxlovid. In clinical trials, molnupiravir was shown to reduce the risk of covid-related hospitalization and death by 30%, compared to the expected 50% efficacy the company previously claimed, citing their interim data. There are also some additional security issues on molnupiravir, which relies on causing mutations in the coronavirus using a mechanism that could theoretically affect human cells as well (in studies, Paxlovid showed no such potential risk). These risks are not definitive, but they may limit the use of molnupiravir, such as avoiding its use in people who are considering becoming pregnant.

Another issue that could affect the success of either treatment is whether Americans will have access to them. The Biden Administration has: secured the supply of 10 million doses of Paxlovid and committed to making it readily available and free of charge.


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