- PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir
tablets) is authorized by the U.S. FDA for emergency use in both
high-risk adults and high-risk pediatric patients 12 years of age
and older weighing at least 40 kg
- A total of 20 million treatment courses will be delivered to
the U.S. government in 2022, with approximately 10 million
treatment courses accelerated for delivery by the end of June
Pfizer Inc. (NYSE: PFE) announced that the U.S. government has
committed to purchasing an additional 10 million treatment courses
of its COVID-19 oral therapy, PAXLOVID™ (nirmatrelvir [PF-07321332]
tablets and ritonavir tablets). This commitment will supplement the
10 million treatment courses previously contracted by the U.S.
Government, bringing the total amount of treatment courses to 20
million. Collectively, approximately 10 million PAXLOVID treatment
courses have been accelerated for delivery by the end of June, with
the remaining 10 million to follow by the end of September.
“With the Omicron variant surging, the availability of and
accessibility to treatment options is of utmost importance, as
millions of people are being diagnosed with COVID-19 each and every
day,” said Albert Bourla, Chairman and Chief Executive Officer,
Pfizer. “With data showing significant reductions in
hospitalizations and deaths, along with the potential for PAXLOVID
to maintain robust antiviral activity against Omicron, we believe
this therapy will be an important tool in the fight against
COVID-19. We are pleased to be working with the U.S. government to
help broaden patient access to this potentially game changing
therapy.”
PAXLOVID includes nirmatrelvir, a novel main protease (Mpro)
inhibitor originating in Pfizer’s laboratories, which was
specifically designed to block the activity of the SARS-CoV-2 Mpro,
an enzyme that the coronavirus needs to replicate. The U.S. Food
and Drug Administration (FDA) recently authorized the emergency use
of PAXLOVID for the treatment of mild-to-moderate COVID-19 in
adults and pediatric patients (12 years of age and older weighing
at least 40 kg [88 lbs]) with positive results of direct SARS-CoV-2
viral testing, and who are at high risk for progression to severe
COVID-19, including hospitalization or death.
PAXLOVID is also currently authorized for conditional or
emergency use in several countries across the globe. Pfizer has
submitted applications for regulatory approval or authorization to
multiple regulatory agencies and anticipates further regulatory
decisions to follow.
Please see Full Emergency Use Authorization (EUA) Prescribing
Information available at www.fda.gov and www.COVID19oralRx.com.
Under the EUA, the U.S. Government and State Governments decide how
PAXLOVID is distributed among pharmacies, hospitals, urgent cares,
and other entities. Healthcare providers and healthcare facilities
should contact their state health department to determine how to
access product. Additional information about how the U.S.
Department of Health and Human Services will supply PAXLOVID can be
found at www.PHE.gov and
https://www.hhs.gov/coronavirus/covid-19-treatments-therapeutics/index.html.
Locations of publicly available COVID-19 Therapeutics can be found
at COVID-19 Public Therapeutic Locator | HealthData.gov.
Our Commitment to Equitable Access Pfizer is committed to
working toward equitable access to PAXLOVID for all people, aiming
to deliver safe and effective antiviral therapeutics as soon as
possible and at an affordable price. During the pandemic, Pfizer
will offer its oral therapy through a tiered pricing approach,
pending country authorization or approval, based on the income
level of each country to promote equity of access across the globe.
High and upper-middle income countries will pay more than lower
income countries.
Pfizer continues to invest to support the manufacturing and
distribution of PAXLOVID, including exploring potential contract
manufacturing options. As a result of these efforts, Pfizer is
raising its production projections from 80 million to 120 million
courses of treatment by the end of 2022.
The company has entered into agreements with multiple countries
and has initiated bilateral outreach to approximately 100 countries
around the world. Additionally, Pfizer has signed a voluntary
license agreement with the Medicines Patent Pool (MPP) for its oral
treatment to help expand access, pending country regulatory
authorization or approval, in 95 low- and middle-income countries
that account for approximately 53% of the world’s population.
About PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and
ritonavir tablets) PAXLOVID is a SARS-CoV-2 main protease
(Mpro) inhibitor (also known as SARS-CoV2 3CL protease inhibitor)
therapy. It was developed to be administered orally so that it can
be prescribed at the first sign of infection or, pending clinical
success of the rest of the EPIC development program and subject to
regulatory authorization, at first awareness of an exposure –
potentially helping patients avoid severe illness (which can lead
to hospitalization and death) or avoid disease development
following contact with a household member who contracts COVID-19.
Nirmatrelvir [PF-07321332], which originated in Pfizer
laboratories, is designed to block the activity of the Mpro, an
enzyme that the coronavirus needs to replicate. Co-administration
with a low dose of ritonavir helps slow the metabolism, or
breakdown, of nirmatrelvir in order for it to remain active in the
body for longer periods of time at higher concentrations to help
combat the virus.
Nirmatrelvir is designed to inhibit viral replication at a stage
known as proteolysis, which occurs before viral RNA replication. In
preclinical studies, nirmatrelvir did not demonstrate evidence of
mutagenic DNA interactions.
Current variants of concern can be resistant to treatments that
inhibit the spike protein found on the surface of the SARS-CoV-2
virus, due to its high mutation rate. PAXLOVID, however, works
intracellularly by binding to the protease of the SARS-CoV-2 virus
to inhibit viral replication. Nirmatrelvir has shown consistent in
vitro antiviral activity against current variants of concern (i.e.,
alpha, beta, delta, gamma, lambda, and mu). In addition,
nirmatrelvir potently inhibited the Mpro associated with Omicron in
an in vitro biochemical assay. This indicates nirmatrelvir’s
potential to maintain robust antiviral activity against Omicron.
Additional in vitro antiviral studies with this variant are
underway.
PAXLOVID is authorized to be administered at a dose of 300 mg
(two 150 mg tablets) of nirmatrelvir with one 100 mg tablet of
ritonavir, given twice-daily for five days. One carton contains
five blister packs of PAXLOVID, as co-packaged nirmatrelvir tablets
with ritonavir tablets, providing all required doses for a full
five-day treatment course.
Emergency Use Authorization Statement PAXLOVID has not
been approved, but has been authorized for emergency use by FDA
under an EUA, for the treatment of mild-to-moderate COVID-19 in
adults and pediatric patients (12 years of age and older weighing
at least 40 kg) with positive results of direct SARS CoV-2 viral
testing, and who are at high-risk for progression to severe
COVID-19, including hospitalization or death.
The emergency use of PAXLOVID is only authorized for the
duration of the declaration that circumstances exist justifying the
authorization of the emergency use of drugs and biological products
during the COVID-19 pandemic under Section 564(b)(1) of the Act, 21
U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or
authorization revoked sooner.
AUTHORIZED USE
The U.S. Food and Drug Administration (FDA) has issued an
Emergency Use Authorization (EUA) for the emergency use of the
unapproved product PAXLOVID for the treatment of mild-to-moderate
coronavirus disease 2019 (COVID-19) in adults and pediatric
patients (12 years of age and older weighing at least 40 kg) with
positive results of direct severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) viral testing, and who are at high risk
for progression to severe COVID-19, including hospitalization or
death.
LIMITATIONS OF AUTHORIZED USE
- PAXLOVID is not authorized for initiation of treatment in
patients requiring hospitalization due to severe or critical
COVID-19
- PAXLOVID is not authorized for use as pre-exposure or
post-exposure prophylaxis for prevention of COVID-19
- PAXLOVID is not authorized for use for longer than 5
consecutive days
PAXLOVID may only be prescribed for an individual patient by
physicians, advanced practice registered nurses, and physician
assistants that are licensed or authorized under state law to
prescribe drugs in the therapeutic class to which PAXLOVID belongs
(i.e., anti-infectives).
PAXLOVID is not approved for any use, including for use for the
treatment of COVID-19.
PAXLOVID is authorized only for the duration of the declaration
that circumstances exist justifying the authorization of the
emergency use of PAXLOVID under 564(b)(1) of the Food Drug and
Cosmetic Act unless the authorization is terminated or revoked
sooner.
IMPORTANT SAFETY INFORMATION
PAXLOVID is contraindicated in patients with a history of
clinically significant hypersensitivity reactions (eg, toxic
epidermal necrolysis [TEN] or Stevens-Johnson syndrome) to its
active ingredients (nirmatrelvir or ritonavir) or any other
components of the product.
PAXLOVID is contraindicated with drugs that are highly
dependent on CYP3A for clearance and for which elevated
concentrations are associated with serious and/or life-threatening
reactions:
- Alpha1-adrenoreceptor antagonist: alfuzosin
- Analgesics: pethidine, piroxicam, propoxyphene
- Antianginal: ranolazine
- Antiarrhythmic: amiodarone, dronedarone, flecainide,
propafenone, quinidine
- Anti-gout: colchicine
- Antipsychotics: lurasidone, pimozide, clozapine
- Ergot derivatives: dihydroergotamine, ergotamine,
methylergonovine
- HMG-CoA reductase inhibitors: lovastatin, simvastatin
- PDE5 inhibitor: sildenafil (Revatio®) when used for pulmonary
arterial hypertension
- Sedative/hypnotics: triazolam, oral midazolam
PAXLOVID is contraindicated with drugs that are potent CYP3A
inducers where significantly reduced nirmatrelvir or ritonavir
plasma concentrations may be associated with the potential for loss
of virologic response and possible resistance. PAXLOVID cannot be
started immediately after discontinuation of any of the following
medications due to the delayed offset of the recently discontinued
CYP3A inducer:
- Anticancer agents: apalutamide
- Anticonvulsant: carbamazepine, phenobarbital, phenytoin
- Antimycobacterials: rifampin
- Herbal Products: St. John’s Wort (hypericum perforatum)
There are limited clinical data available for PAXLOVID.
Serious and unexpected adverse events may occur that have
not been previously reported with PAXLOVID use.
Risk of Serious Adverse Reactions Due to Drug
Interactions: Initiation of PAXLOVID, a CYP3A inhibitor, in
patients receiving medications metabolized by CYP3A or initiation
of medications metabolized by CYP3A in patients already receiving
PAXLOVID, may increase plasma concentrations of medications
metabolized by CYP3A. Initiation of medications that inhibit or
induce CYP3A may increase or decrease concentrations of PAXLOVID,
respectively. These interactions may lead to:
- Clinically significant adverse reactions, potentially leading
to severe, life-threatening, or fatal events from greater exposures
of concomitant medications
- Clinically significant adverse reactions from greater exposures
of PAXLOVID
- Loss of therapeutic effect of PAXLOVID and possible development
of viral resistance
Consult Table 1 of the Fact Sheet for Healthcare Providers for
clinically significant drug interactions, including contraindicated
drugs. Consider the potential for drug interactions prior to and
during PAXLOVID therapy; review concomitant medications during
PAXLOVID therapy and monitor for the adverse reactions associated
with the concomitant medications.
Hepatotoxicity: Hepatic transaminase elevations, clinical
hepatitis, and jaundice have occurred in patients receiving
ritonavir. Therefore, caution should be exercised when
administering PAXLOVID to patients with pre-existing liver
diseases, liver enzyme abnormalities, or hepatitis.
Because nirmatrelvir is co-administered with ritonavir, there
may be a risk of HIV-1 developing resistance to HIV
protease inhibitors in individuals with uncontrolled or
undiagnosed HIV-1 infection.
Adverse events in the PAXLOVID group (≥1%) that occurred
at a greater frequency (≥5 subject difference) than in the placebo
group were dysgeusia (6% and <1%, respectively), diarrhea (3%
and 2%), and hypertension (1% and <1%), and myalgia (1% and
<1%). The proportions of subjects who discontinued treatment due
to an adverse event were 2% in the PAXLOVID group and 4% in the
placebo group.
Required Reporting for Serious Adverse Events and Medication
Errors: The prescribing healthcare provider and/or the
provider’s designee are/is responsible for mandatory reporting of
all serious adverse events and medication errors potentially
related to PAXLOVID within 7 calendar days from the onset of the
event.
Submit adverse event and medication error reports to FDA
MedWatch using one of the following methods:
- Online: https://www.fda.gov/medwatch/report.htm
- Complete and submit a postage-paid FDA Form 3500 and returning
by mail/fax
- Call 1-800-FDA-1088 to
request a reporting form
In addition, please provide a copy of all FDA MedWatch forms to:
www.pfizersafetyreporting.com, or by fax (1-866-635-8337) or phone
(1-800-438-1985).
PAXLOVID is an inhibitor of CYP3A and may increase plasma
concentrations of drugs that are primarily metabolized by CYP3A.
Co-administration of PAXLOVID with drugs highly dependent on CYP3A
for clearance and for which elevated plasma concentrations are
associated with serious and/or life-threatening events is
contraindicated. Co-administration with other CPY3A substrates may
require a dose adjustment or additional monitoring.
Nirmatrelvir and ritonavir are CYP3A substrates; therefore,
drugs that induce CYP3A may decrease nirmatrelvir and ritonavir
plasma concentrations and reduce PAXLOVID therapeutic effect.
Pregnancy: There are no available human data on the use
of nirmatrelvir during pregnancy to evaluate for a drug-associated
risk of major birth defects, miscarriage, or adverse maternal or
fetal outcomes. Published observational studies on ritonavir use in
pregnant women have not identified an increase in the risk of major
birth defects. Published studies with ritonavir are insufficient to
identify a drug-associated risk of miscarriage. There are maternal
and fetal risks associated with untreated COVID-19 in
pregnancy.
Lactation: There are no available data on the presence of
nirmatrelvir in human or animal milk, the effects on the breastfed
infant, or the effects on milk production. A transient decrease in
body weight was observed in the nursing offspring of rats
administered nirmatrelvir. Limited published data reports that
ritonavir is present in human milk. There is no information on the
effects of ritonavir on the breastfed infant or the effects of the
drug on milk production. The developmental and health benefits of
breastfeeding should be considered along with the mother's clinical
need for PAXLOVID and any potential adverse effects on the
breastfed infant from PAXLOVID or from the underlying maternal
condition. Breastfeeding individuals with COVID-19 should follow
practices according to clinical guidelines to avoid exposing the
infant to COVID-19.
Contraception: Use of ritonavir may reduce the efficacy
of combined hormonal contraceptives. Advise patients using combined
hormonal contraceptives to use an effective alternative
contraceptive method or an additional barrier method of
contraception.
Pediatrics: PAXLOVID is not authorized for use in
pediatric patients younger than 12 years of age or weighing less
than 40 kg. The safety and effectiveness of PAXLOVID have not been
established in pediatric patients. The authorized adult dosing
regimen is expected to result in comparable serum exposures of
nirmatrelvir and ritonavir in patients 12 years of age and older
and weighing at least 40 kg as observed in adults, and adults with
similar body weight were included in the trial EPIC-HR.
Systemic exposure of nirmatrelvir increases in renally impaired
patients with increase in the severity of renal impairment. No
dosage adjustment is needed in patients with mild renal impairment.
In patients with moderate renal impairment (eGFR ≥30 to <60
mL/min), reduce the dose of PAXLOVID to 150 mg nirmatrelvir and
100 mg ritonavir twice daily for 5 days. Prescriptions should
specify the numeric dose of each active ingredient within PAXLOVID.
Providers should counsel patients about renal dosing instructions.
PAXLOVID is not recommended in patients with severe renal
impairment (eGFR <30 mL/min based on CKD-EPI formula) until
more data are available; the appropriate dosage for patients with
severe renal impairment has not been determined.
No dosage adjustment of PAXLOVID is needed for patients with
either mild (Child-Pugh Class A) or moderate (Child-Pugh Class B)
hepatic impairment. No pharmacokinetic or safety data are available
regarding the use of nirmatrelvir or ritonavir in subjects with
severe hepatic impairment (Child-Pugh Class C); therefore,
PAXLOVID is not recommended for use in patients with severe
hepatic impairment.
About Pfizer: Breakthroughs That Change Patients’ Lives
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products, including innovative medicines and vaccines. Every day,
Pfizer colleagues work across developed and emerging markets to
advance wellness, prevention, treatments and cures that challenge
the most feared diseases of our time. Consistent with our
responsibility as one of the world's premier innovative
biopharmaceutical companies, we collaborate with health care
providers, governments and local communities to support and expand
access to reliable, affordable health care around the world. For
more than 170 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on
Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us
on Facebook at Facebook.com/Pfizer.
Disclosure Notice The information contained in this
release is as of January 4, 2022. Pfizer assumes no obligation to
update forward-looking statements contained in this release as the
result of new information or future events or developments.
This release contains forward-looking information about Pfizer’s
efforts to combat COVID-19 and PAXLOVID (including qualitative
assessments of available data, potential benefits, expectations for
clinical trials, a commitment by the U.S. government to purchase
additional treatment courses of PAXLOVID and the timing of delivery
of doses to the U.S. government, other advanced purchase agreements
and an agreement with MPP, efforts toward equitable access, the
anticipated timing of data readouts, regulatory submissions,
regulatory approvals or authorizations, potential to maintain
antiviral activity against variants, planned investment and
anticipated manufacturing, distribution and supply), involving
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for clinical trials, regulatory submission
dates, regulatory approval dates and/or launch dates, as well as
risks associated with preclinical and clinical data, including the
possibility of unfavorable new preclinical, clinical or safety data
and further analyses of existing preclinical, clinical or safety
data, including the risk that final results from EPIC-SR could
differ from the interim data; the ability to produce comparable
clinical or other results including efficacy, safety and
tolerability profile observed to date, in additional studies or in
larger, more diverse populations following commercialization; the
risk that serious and unexpected adverse events may occur that have
not been previously reported with PAXLOVID use; the risk that
preclinical and clinical trial data are subject to differing
interpretations and assessments, including during the peer
review/publication process, in the scientific community generally,
and by regulatory authorities; whether regulatory authorities will
be satisfied with the design of and results from these and any
future preclinical and clinical studies; whether and when any drug
applications or submissions to request emergency use or conditional
marketing authorization for any potential indications for PAXLOVID
may be filed in particular jurisdictions and if obtained, whether
or when such emergency use authorization or licenses will expire or
terminate; whether and when regulatory authorities in any
jurisdictions may approve any applications or submissions for
PAXLOVID that may be pending or filed (including the potential NDA
submission in the U.S. and submissions in other jurisdictions),
which will depend on myriad factors, including making a
determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy and, if
approved, whether it will be commercially successful; decisions by
regulatory authorities impacting labeling or marketing,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of PAXLOVID,
including development of products or therapies by other companies;
risks related to the availability of raw materials for PAXLOVID;
the risk that we may not be able to create or scale up
manufacturing capacity on a timely basis or maintain access to
logistics or supply channels commensurate with global demand, which
would negatively impact our ability to supply the estimated numbers
of courses of PAXLOVID within the projected time periods; whether
and when a definitive agreement for the commitment will be reached;
whether and when additional purchase agreements will be reached;
the risk that demand for any products may be reduced or no longer
exist; uncertainties regarding the impact of COVID-19 on Pfizer’s
business, operations and financial results; and competitive
developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2020 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
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