FDA Approves First Antiviral COVID-19 Treatment Pill For At-Home Use

By Patrick Goodenough | December 22, 2021 | 11:34pm EST
(Photo by Timothy A. Clary/AFP via Getty Images)
(Photo by Timothy A. Clary/AFP via Getty Images)

(CNSNews.com) – The Food and Drug Administration on Wednesday granted emergency use authorization (EUA) in the U.S. for the first antiviral pill against COVID-19 – a product whose makers say can reduce the chance of hospitalization or death by almost 90 percent in patients most likely to get severe disease.

Pfizer's prescription-only treatment, Paxlovid, comprises two separate drugs (nirmatrelvir and ritonavir) taken together twice-daily over a five-day period, to treat mild-to-moderate disease in patients 12 years and older, at high risk of becoming severely ill.

Among the advantages, the oral medication can be taken at home and is easier to administer than monoclonal antibody drugs used up to now in the pandemic, which are delivered via injection or IV infusion, typically at a medical facility.

At $530 per course (according to a U.S. government contract to buy 10 million treatment courses), Paxlovid is also considerably cheaper than monoclonal antibody drugs.

Also, Pfizer reports that nirmatrelvir, one of the two drugs making up the Paxlovid treatment, appears to “maintain robust antiviral activity against” the omicron strain of the coronavirus, although ongoing research is underway.

By contrast, recent lab test data suggest that some of the monoclonal antibody drugs currently being used in the U.S. are not effective against omicron, which the CDC says has now become the dominant strain of the virus in the U.S.

Weighed against the pros offered by Paxlovid, the treatment course should be initiated within five days of the onset of symptoms, according to the FDA. Within those five days, a person experiencing symptoms will need to have a test, get the result, consult a doctor for a prescription, get the prescription filled, and begin the course.

Supplies of Paxlovid will be limited to begin with, although Pfizer last month announced an agreement with the federal government to supply 10 million courses, “with delivery fulfillment expected to be completed in 2022.”

White House coronavirus response coordinator Jeff Zients told a briefing Wednesday 265,000 treatment courses would be available in January, with all 10 million “delivered by late summer.”

Trials

Pfizer bases its assertions about effectiveness on clinical trials involving more than 2,000 unvaccinated adults with confirmed COVID-19 infection and at risk of severe illness. Roughly half received its treatment and the other half a placebo.

“Paxlovid significantly reduced the proportion of people with COVID-19 related hospitalization or death from any cause by 88% compared to placebo among patients treated within five days of symptom onset and who did not receive COVID-19 therapeutic monoclonal antibody treatment,” the FDA said in explaining its EUA decision.

Pfizer reported an 89 percent reduction in the risk of COVID-19-related hospitalization or death in those who received Paxlovid within three days of symptom onset, and 88 percent in those who received it within five days of the symptoms beginning.

By the 28th day of monitoring, no deaths had been reported in the treatment group, compared to nine deaths among those given the placebo, it said.

“We received good news today in our fight against COVID-19,” said President Biden, calling the pills “a promising new treatment option that will significantly reduce hospitalization and death as we battle the more transmissible Omicron variant.”

Last week, the FDA’s European Union equivalent, the European Medicines Agency issued advice to E.U. member-states that Paxlovid may be used to treat COVID-19-positive adults who do not require supplemental oxygen and who are at increased risk of becoming seriously ill.

Pfizer says it has submitted applications for authorization or approval to multiple regulatory bodies around the world and expects more such decisions to follow.

Wednesday’s announcement came four months after the FDA gave full approval for the Pfizer-BioNTech COVID-19 vaccine. Earlier, it granted EUA for the Pfizer-BioNTech product in December 2020, for the Moderna vaccine later that same month, and for the Janssen vaccine in February.

The FDA said it continues to urge the public to get vaccinated and receive a booster if eligible.

“Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

MRC Store