FDA NEWS RELEASE

Coronavirus (COVID-19) Update: FDA

Authorizes First Oral Antiviral for Treatment
of COVID-19
For Immediate
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December 22, 2021

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Today, the U.S. Food and Drug Administration issued an emergency

use authorization (EUA)
(https://www.fda.gov/media/155049/download) for Pfizer’s Paxlovid
(nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for
the treatment of mild-to-moderate coronavirus disease (COVID-19) in
adults and pediatric patients (12 years of age and older weighing at
least 40 kilograms or about 88 pounds) with positive results of direct
SARS-CoV-2 testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death. Paxlovid is available by
prescription only and should be initiated as soon as possible after
diagnosis of COVID-19 and within five days of symptom onset.

“Today’s authorization introduces the first treatment for

COVID-19 that is in the form of a pill that is taken orally — a
major step forward in the fight against this global
pandemic,” said Patrizia Cavazzoni, M.D., director of the
FDA’s Center for Drug Evaluation and Research. “This
authorization provides a new tool to combat COVID-19 at a
crucial time in the pandemic as new variants emerge and
promises to make antiviral treatment more accessible to
patients who are at high risk for progression to severe
COVID-19.”

Paxlovid is not authorized for the pre-exposure or post-exposure

prevention of COVID-19 or for initiation of treatment in those
requiring hospitalization due to severe or critical COVID-19. Paxlovid
is not a substitute for vaccination in individuals for whom COVID-19
vaccination and a booster dose are recommended. The FDA has
approved one vaccine and authorized others to prevent COVID-19 and
serious clinical outcomes associated with a COVID-19 infection,
including hospitalization and death. The FDA urges the public to get
vaccinated and receive a booster if eligible. Learn more about FDA-
approved or -authorized COVID-19 vaccines
(https://www.fda.gov/emergency-preparedness-and-
response/coronavirus-disease-2019-covid-19/covid-19-vaccines).
Paxlovid consists of nirmatrelvir, which inhibits a SARS-CoV-2 protein
to stop the virus from replicating, and ritonavir, which slows down
nirmatrelvir’s breakdown to help it remain in the body for a longer
period at higher concentrations. Paxlovid is administered as three
tablets (two tablets of nirmatrelvir and one tablet of ritonavir) taken
together orally twice daily for five days, for a total of 30 tablets.
Paxlovid is not authorized for use for longer than five consecutive
days.

The issuance of an EUA is different than an FDA approval. In

determining whether to issue an EUA, the FDA evaluates the totality of
scientific evidence available and carefully balances any known or
potential risks with any known or potential benefits of the product.
Based on the FDA’s review of the totality of the scientific evidence
available, the agency has determined that it is reasonable to believe
that Paxlovid may be effective for the treatment of mild-to-moderate
COVID-19 in authorized patients. The agency has also determined that
the known and potential benefits of Paxlovid, when used consistent
with the terms and conditions of the authorization, outweigh the
known and potential risks of the product. There are no adequate,
approved and available alternatives to Paxlovid for the treatment of
COVID-19.

The primary data supporting this EUA for Paxlovid are from EPIC-HR,
a randomized, double-blind, placebo-controlled clinical trial studying
Paxlovid for the treatment of non-hospitalized symptomatic adults
with a laboratory confirmed diagnosis of SARS-CoV-2 infection.
Patients were adults 18 years of age and older with a prespecified risk
factor for progression to severe disease or were 60 years and older
regardless of prespecified chronic medical conditions. All patients had
not received a COVID-19 vaccine and had not been previously infected
with COVID-19. The main outcome measured in the trial
(https://clinicaltrials.gov/ct2/show/NCT04960202) was the
proportion of people who were hospitalized due to COVID-19 or died
due to any cause during 28 days of follow-up. 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. In
this analysis, 1,039 patients had received Paxlovid, and 1,046 patients
had received placebo and among these patients, 0.8% who received
Paxlovid were hospitalized or died during 28 days of follow-up
compared to 6% of the patients who received placebo. The safety and
effectiveness of Paxlovid for the treatment of COVID-19 continue to be
evaluated.

Possible side effects of Paxlovid include impaired sense of taste,

diarrhea, high blood pressure and muscle aches. Using Paxlovid at the
same time as certain other drugs may result in potentially significant
drug interactions. Using Paxlovid in people with uncontrolled or
undiagnosed HIV-1 infection may lead to HIV-1 drug resistance.
Ritonavir may cause liver damage, so caution should be exercised
when giving Paxlovid to patients with preexisting liver diseases, liver
enzyme abnormalities or liver inflammation.

Because Paxlovid works, in part, by inhibiting a group of enzymes that

break down certain drugs, Paxlovid is contraindicated with certain
drugs that are highly dependent on those enzymes for metabolism and
for which elevated concentrations of certain drugs are associated with
serious and/or life-threatening reactions. Paxlovid is also
contraindicated with drugs that, conversely, strongly induce those
same enzymes, leading to the faster breakdown of nirmatrelvir or
ritonavir, as reduced concentrations of nirmatrelvir or ritonavir may be
associated with potentially losing virologic response and developing
viral resistance. Paxlovid cannot be started immediately after
discontinuing such medications because the effects of those
medications remain after discontinuation. For a complete list of drugs
that should not be taken in combination with Paxlovid, see the fact
sheet (https://www.fda.gov/media/155050/download) for healthcare
providers.

Paxlovid is not recommended in patients with severe kidney or severe

liver impairment. In patients with moderate renal impairment, a
reduced Paxlovid dose is needed. Patients with kidney or liver
problems should discuss with their healthcare provider whether
Paxlovid is right for them.

Under the EUA, fact sheets that provide important information about
using Paxlovid in the treatment of COVID-19 as authorized must be
made available to healthcare providers
(https://www.fda.gov/media/155050/download) and to patients and
caregivers (https://www.fda.gov/media/155051/download). These fact
sheets include dosing instructions, potential side effects, drug
interactions and information about who is able to prescribe Paxlovid.

Related Information
Paxlovid EUA Letter of Authorization
(https://www.fda.gov/media/155049/download)

Frequently Asked Questions on the Emergency Use

Authorization for Paxlovid
(https://www.fda.gov/media/155052/download)

Emergency Use Authorization: Drugs and Non-Vaccine

Biological Products (https://www.fda.gov/emergency-
preparedness-and-response/mcm-legal-regulatory-and-policy-
framework/emergency-use-authorization#coviddrugs)

Coronavirus Disease (COVID-19)

 (https://www.fda.gov/emergency-preparedness-and-
response/counterterrorism-and-emerging-threats/coronavirus-
disease-2019-covid-19)

Coronavirus Treatment Acceleration Program (CTAP)

(https://www.fda.gov/drugs/coronavirus-covid-19-
drugs/coronavirus-treatment-acceleration-program-ctap)

###

The FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices. The
agency also is responsible for the safety and security of our nation’s
food supply, cosmetics, dietary supplements, products that give off
electronic radiation, and for regulating tobacco products.

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