The Companies Are Committed To Providing
Timely Access to Molnupiravir Through Comprehensive Supply and
Access Approach
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics today announced that the U.S.
Food and Drug Administration (FDA) has granted Emergency Use
Authorization (EUA) for molnupiravir, an investigational oral
antiviral (MK-4482, EIDD-2801). Molnupiravir has not been approved,
but has been authorized for emergency use by the FDA under an EUA
to treat mild to moderate coronavirus disease 2019 (COVID-19) in
adults 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, and for whom alternative
COVID-19 treatment options authorized by the FDA are not accessible
or clinically appropriate. Molnupiravir is not authorized for use
in patients who are less than 18 years of age, for initiation of
treatment in patients hospitalized due to COVID-19, for use for
longer than five consecutive days, or for pre-exposure or
post-exposure prophylaxis for prevention of COVID-19.
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“The FDA Emergency Use Authorization of molnupiravir is an
important milestone in the fight against COVID-19, and adds to
Merck’s legacy of bringing forward innovative medicines that both
address the world’s greatest health threats and help save lives.
Because we recognized the promise of molnupiravir early, Merck
invested at risk and we are executing an unprecedented global
access strategy so that molnupiravir, now authorized, can be
available to patients here in the U.S. and all around the world
more quickly and more equitably than has ever been accomplished
before,” said Robert M. Davis, chief executive officer and
president, Merck.
Molnupiravir should be administered as soon as possible after a
diagnosis of COVID-19 has been made, and within five days of
symptom onset. The recommended dose for molnupiravir is 800 mg
(four 200 mg capsules) taken orally every 12 hours for five days,
with or without food. Completion of the full five-day treatment
course is important to maximize viral clearance and minimize
transmission of SARS-CoV-2.
Molnupiravir is not recommended for use in patients who are
pregnant. Based on findings from animal reproduction studies,
molnupiravir may cause fetal harm when administered to pregnant
individuals. There are no available human data on the use of
molnupiravir in pregnant individuals to evaluate the risk of major
birth defects, miscarriage or adverse maternal or fetal outcomes.
Before initiating treatment with molnupiravir, it should be
assessed whether an individual of childbearing potential is
pregnant or not, if clinically indicated. Females of childbearing
potential should use a reliable method of contraception correctly
and consistently, as applicable, for the duration of treatment and
for four days after the last dose of molnupiravir. Males of
reproductive potential who are sexually active with females of
childbearing potential should use a reliable method of
contraception correctly and consistently during treatment and for
at least three months after the last dose. There is a pregnancy
surveillance program that monitors pregnancy outcomes in
individuals exposed to molnupiravir during pregnancy. Patients
exposed to molnupiravir during pregnancy should report the exposure
by contacting Merck by phone at 1-877-888-4231, or online at
pregnancyreporting.msd.com. For more information, see “Selected
Safety Information” below.
The authorization is based on the Phase 3 MOVe-OUT trial, which
evaluated molnupiravir 800 mg twice-daily in non-hospitalized adult
patients who were unvaccinated against SARS-CoV-2, had
laboratory-confirmed SARS-CoV-2 infection, symptom onset within
five days of study randomization, and at least one risk factor
associated with poor disease outcomes (e.g., heart disease,
diabetes).
In analyses from all randomized patients (n=1433), molnupiravir
reduced the risk of hospitalization or death: 9.7% (68/699) of
patients in the placebo group were hospitalized or died compared to
6.8% (48/709) of patients who received molnupiravir, for an
absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1,
5.9). Nine deaths were reported in the placebo group, and one in
the molnupiravir group.
The determination of primary efficacy was based on a planned
interim analysis of 762 subjects. At the interim analysis,
treatment with molnupiravir significantly reduced hospitalizations
and death through Day 29 following randomization: 14.1% (53/377) of
patients in the placebo group were hospitalized or died, compared
to 7.3% (28/385) of patients who received molnupiravir. The
absolute risk reduction between the molnupiravir and the placebo
arm was 6.8 percentage points (95% CI: 2.4, 11.3; p=0.0024).
In the clinical study, the most common adverse reactions for
molnupiravir (incidence ≥1%) were diarrhea (2% for molnupiravir, 2%
for placebo), nausea (1% for molnupiravir, 1% for placebo) and
dizziness (1% for molnupiravir, 1% for placebo). Discontinuation of
study intervention due to an adverse event (AE) occurred in 1% of
subjects receiving molnupiravir and 3% of subjects receiving
placebo. Serious AEs occurred in 7% of subjects receiving
molnupiravir and 10% receiving placebo; most serious AEs were
COVID-19 related.
“Based on the strong science behind molnupiravir – a single oral
medicine that interrupts replication of the SARS-CoV-2 virus, with
data demonstrating a significant reduction in the risk of
hospitalizations and deaths – molnupiravir has the potential to
become an important tool for healthcare professionals and
appropriate patients,” said Dr. Dean Y. Li, president, Merck
Research Laboratories. “We are immensely grateful to all of our
collaborators, including trial patients and clinical investigators,
for their important contributions to this milestone.”
Merck anticipates that it will begin shipping molnupiravir to
AmerisourceBergen, the sole distributor of molnupiravir, within
days. As previously announced, Merck entered into a procurement
agreement with the U.S. Government under which, to date, the
company has agreed to supply approximately 3.1 million courses of
molnupiravir to the U.S. Government, upon EUA from the FDA.
“Before the virus that caused this tragic pandemic had a name,
the team at Ridgeback saw the need for urgent action. We joined
with George Painter, Drug Research Innovations at Emory (DRIVE) and
Merck with the hope of taking molnupiravir from a dream to the
reality we see today,” said Wendy Holman, chief executive officer,
Ridgeback Biotherapeutics. “There is now a prescription oral
antiviral, molnupiravir, for use by appropriate high-risk patients,
that can be taken at home, as soon as possible after an appropriate
patient tests positive for COVID-19, to help reduce the risk of
hospitalization or death. It’s an oral therapeutic option with no
known drug-drug interactions and without required dose
modifications for those with impaired kidney or liver function. We
are thrilled this tremendous global collaboration between
Ridgeback, Merck and DRIVE has fulfilled our hopes of bringing
forward an oral medicine to help keep people out of the hospital
and alive.”
Molnupiravir is also being evaluated for post-exposure
prophylaxis in MOVe-AHEAD, a global, multicenter, randomized,
double-blind, placebo-controlled Phase 3 study, which is evaluating
the efficacy and safety of molnupiravir in preventing the spread of
COVID-19 within households. Molnupiravir is not authorized for
pre-exposure or post-exposure prophylaxis for prevention of
COVID-19.
An EUA is an FDA authorization for the emergency use of an
unapproved product or unapproved use of an approved product in the
U.S. under certain circumstances, including a public health
emergency. Molnupiravir is an investigational treatment and is
still under review by the FDA.
Recently, the FDA Antimicrobial Drugs Advisory Committee (AMDAC)
voted that the known and potential benefits of molnupiravir
outweigh its known and potential risks for the treatment of mild to
moderate COVID-19 in high risk adult patients who are within five
days of symptom onset. Molnupiravir has received conditional
marketing authorization in the United Kingdom for the treatment of
mild to moderate COVID-19 in adults with a positive SARS-CoV-2
diagnostic test and who have at least one risk factor for
developing severe illness. The European Medicines Agency (EMA)
issued a positive scientific opinion for molnupiravir under Article
5.3 Regulation 726/2004, which is intended to support national
decision-making on the possible use of molnupiravir prior to
marketing authorization. Applications to other regulatory bodies
worldwide are underway.
About Merck’s Global Efforts to Accelerate Access to
Molnupiravir Following Regulatory Authorizations or
Approvals
Global access has been a priority for Merck and Ridgeback since
the inception of their molnupiravir collaboration. The companies
are committed to providing timely access to molnupiravir globally
through our comprehensive supply and access approach, which
includes investing at risk to produce millions of courses of
therapy; tiered pricing based on the ability of governments to
finance health care; entering into supply agreements with
governments; and granting voluntary licenses to generic
manufacturers and to the Medicines Patent Pool to make generic
molnupiravir available in more than 100 low- and middle-income
countries following local regulatory authorizations or
approvals.
Supply: In anticipation of the results from MOVe-OUT and
the potential for regulatory authorization or approval, Merck has
been producing molnupiravir at risk and expects to produce 10
million courses of treatment by the end of 2021, with at least 20
million courses to be produced in 2022.
Supply agreements: Merck entered into a procurement
agreement with the U.S. Government under which the company will
supply approximately 3.1 million courses of molnupiravir to the
U.S. Government, upon Emergency Use Authorization or approval from
the U.S. Food and Drug Administration. Merck has entered into
advance purchase and supply agreements for molnupiravir with the
governments of over 30 countries worldwide, including Australia,
Canada, Korea, Japan, Thailand, United Kingdom and United States,
pending regulatory authorizations, and is currently in discussions
with additional governments. Merck plans to implement a tiered
pricing approach based on World Bank country income criteria to
reflect countries’ relative ability to finance their health
response to the pandemic. In the United States, the purchase was
funded with federal funds from the Biomedical Advanced Research and
Development Authority, part of the U.S. Department of Health and
Human Services’ Office of the Assistant Secretary for Preparedness
and Response, under contract number W911QY-21-C-0031.
Voluntary licenses: As part of its commitment to
widespread global access, Merck previously announced that it has
entered into a licensing agreement with the Medicines Patent Pool
to increase broad access for molnupiravir in low- and middle-income
countries. Additionally, Merck previously announced that the
company has entered into non-exclusive voluntary licensing
agreements for molnupiravir with established generic manufacturers
to accelerate availability of molnupiravir in more than 100 low-
and middle-income countries following approvals or emergency
authorization by local regulatory agencies.
Merck continues to discuss additional measures and
collaborations to accelerate broad, global access to
molnupiravir.
Authorized Use of Molnupiravir
The U.S. Food and Drug Administration (FDA) has issued an EUA
for the emergency use of the unapproved molnupiravir, a nucleoside
analogue that inhibits SARS-CoV-2 replication by viral mutagenesis,
for the treatment of mild to moderate coronavirus disease 2019
(COVID-19) in adults 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, and for whom
alternative COVID-19 treatment options authorized by FDA are not
accessible or clinically appropriate. Molnupiravir is not
FDA-approved for any use including for use for the treatment of
COVID-19. Prior to initiating treatment with molnupiravir,
carefully consider the known and potential risks and benefits.
Molnupiravir is authorized only for the duration of the
declaration that circumstances exist justifying the authorization
of the emergency use of molnupiravir under section 564(b)(1) of the
Federal, Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1),
unless the authorization is terminated or revoked sooner.
Molnupiravir is not authorized for use in patients less than 18
years of age or who are hospitalized due to COVID-19. Benefit of
treatment with molnupiravir has not been observed in subjects when
treatment was initiated after hospitalization due to COVID-19.
Molnupiravir is not authorized for use for longer than five
consecutive days. Molnupiravir is not authorized for pre-exposure
or post-exposure prophylaxis for prevention of COVID-19.
Molnupiravir 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 molnupiravir
belongs (i.e., anti-infectives).
Selected Safety Information for Molnupiravir
Contraindications
No contraindications have been identified based on the limited
available data on the emergency use of molnupiravir authorized
under this EUA.
Warnings and Precautions
There are limited clinical data available for molnupiravir.
Serious and unexpected adverse events may occur that have not been
previously reported with molnupiravir use.
Molnupiravir is not recommended for use during pregnancy. Based
on findings from animal reproduction studies, molnupiravir may
cause fetal harm when administered to pregnant individuals. There
are no available human data on the use of molnupiravir in pregnant
individuals to evaluate the risk of major birth defects,
miscarriage or adverse maternal or fetal outcomes.
Molnupiravir is authorized to be prescribed to a pregnant
individual only after the healthcare provider has determined that
the benefits would outweigh the risks for that individual patient.
If the decision is made to use molnupiravir during pregnancy, the
prescribing healthcare provider must document that the that the
known and potential benefits and the potential risks of using
molnupiravir during pregnancy were communicated to the pregnant
individual.
There is a pregnancy surveillance program that monitors
pregnancy outcomes in individuals exposed to molnupiravir during
pregnancy. The prescribing healthcare provider must document that a
pregnant individual was made aware of Merck’s pregnancy
surveillance program at 1-877-888-4231 or
pregnancyreporting.msd.com. If the pregnant individual agrees to
participate in the pregnancy surveillance program and allows the
prescribing healthcare provider to disclose patient specific
information to Merck, the prescribing healthcare provider must
provide the patient’s name and contact information to Merck.
Pregnant individuals exposed to molnupiravir can also report the
exposure by contacting Merck at 1-877-888-4231 or
pregnancyreporting.msd.com.
Advise individuals of childbearing potential of the potential
risk to a fetus and to use an effective method of contraception
correctly and consistently during treatment with molnupiravir and
for 4 days after the final dose.
Prior to initiating treatment with molnupiravir, assess whether
an individual of childbearing potential is pregnant or not, if
clinically indicated.
Molnupiravir is not authorized for use in patients less than 18
years of age because it may affect bone and cartilage growth. The
safety and efficacy of molnupiravir have not been established in
pediatric patients.
Adverse Reactions
The most common adverse reactions occurring in ≥1% of subjects
in the molnupiravir treatment group in the Phase 3 double-blind
MOVe-OUT study were diarrhea (2% versus placebo at 2%), nausea (1%
versus placebo at 1%), and dizziness (1% versus placebo at 1%) all
of which were Grade 1 (mild) or Grade 2 (moderate).
Serious adverse events occurred in 7% of subjects receiving
molnupiravir and 10% receiving placebo; most serious adverse events
were COVID-19 related. Adverse events leading to death occurred in
2 (<1%) of the subjects receiving molnupiravir and 12 (2%) of
subjects receiving placebo.
Drug Interactions
No drug interactions have been identified based on the limited
available data on the emergency use of molnupiravir. No clinical
drug-drug interaction trials of molnupiravir with concomitant
medications, including other treatments for mild to moderate
COVID-19, have been conducted.
Pregnancy/Breastfeeding
There are no data on the presence of molnupiravir or its
metabolites in human milk. It is unknown whether molnupiravir has
an effect on the breastfed infant or effects on milk production.
Based on the potential for adverse reactions in the infant from
molnupiravir, breastfeeding is not recommended during treatment
with molnupiravir and for 4 days after the final dose. A lactating
individual may consider interrupting breastfeeding and may consider
pumping and discarding breast milk during treatment and for 4 days
after the last dose of molnupiravir.
Males of Reproductive Potential
Nonclinical studies to fully assess the potential for
molnupiravir to affect offspring of treated males have not been
completed. Advise sexually active individuals with partners of
childbearing potential to use a reliable method of contraception
correctly and consistently during treatment and for at least 3
months after last dose of molnupiravir. The risk beyond three
months after the last dose of molnupiravir is unknown.
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
molnupiravir within 7 calendar days from the healthcare provider’s
awareness of the event.
Submit adverse event and medication error reports, using FDA
Form 3500, to FDA MedWatch using one of the following methods:
- Complete and submit the report online:
www.fda.gov/medwatch/report.htm
- Complete and submit a postage-paid FDA Form 3500
(https://www.fda.gov/media/76299/download) and return by:
- Mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787,
or
- Fax to 1-800-FDA-0178
- Call 1-800-FDA-1088 to request a reporting form
In addition, please provide a copy of all FDA MedWatch forms
to:
Merck Sharp & Dohme Corp., a subsidiary
of Merck & Co., Inc., Kenilworth, NJ USA by: Fax: 215-616-5677
E-mail: dpoc.usa@merck.com
About Molnupiravir
Molnupiravir (MK-4482 and EIDD-2801) is an investigational,
orally administered nucleoside analogue that inhibits replication
of SARS-CoV-2, the causative agent of COVID-19. Merck and
Ridgeback’s “orange COVID-19 pill” is a Swedish Orange opaque
capsule with the Merck corporate logo and “82” printed in white
ink, available in certain markets outside of the U.S. as
LAGEVRIO®.
Results from the Phase 3 MOVe-OUT study demonstrated the
efficacy benefit of molnupiravir treatment was generally consistent
across patients infected with SARS-CoV-2 variants of concern,
Delta, Gamma and Mu. Preliminary preclinical data has shown that
molnupiravir has antiviral activity against the newly identified
variant, Omicron (B1.1.529). Molnupiravir has yet to be evaluated
against Omicron in clinical studies.
Molnupiravir was invented at Emory University. Drug Innovation
Ventures at Emory (DRIVE), LLC, which was formed by Emory to
develop early-stage drug candidates for viral diseases of global
concern, advanced molnupiravir through IND submission. Emory/DRIVE
received some research funding from the U.S. Department of Defense
and the U.S. National Institutes of Health. Molnupiravir is being
developed by Merck in collaboration with Ridgeback Biotherapeutics.
Ridgeback received an upfront payment from Merck and also is
eligible to receive contingent payments dependent upon the
achievement of certain developmental and regulatory approval
milestones. Any profits from the collaboration will be split
between the partners equally. Since licensed by Ridgeback, all
funds used for the development of molnupiravir have been provided
by Merck and Ridgeback.
Please visit the Merck media library for molnupiravir images and
b-roll.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is
a biotechnology company focused on emerging infectious diseases.
Ridgeback markets Ebanga™ for the treatment of Ebola and has a
late-stage development pipeline which includes molnupiravir for the
treatment of COVID-19. The team at Ridgeback is dedicated to
developing life-saving and life-changing solutions for patients and
diseases that need champions as well as providing global access to
these medicines. In line with Ridgeback’s mission for equitable
global access, all Ridgeback services and treatment for Ebola
patients in Africa are delivered free of charge.
About Merck
For over 130 years, Merck, known as MSD outside the United
States and Canada, has been inventing for life, bringing forward
medicines and vaccines for many of the world’s most challenging
diseases in pursuit of our mission to save and improve lives. We
demonstrate our commitment to patients and population health by
increasing access to health care through far-reaching policies,
programs and partnerships. Today, Merck continues to be at the
forefront of research to prevent and treat diseases that threaten
people and animals – including cancer, infectious diseases such as
HIV and Ebola, and emerging animal diseases – as we aspire to be
the premier research-intensive biopharmaceutical company in the
world. For more information, visit www.merck.com and connect with
us on Twitter, Facebook, Instagram, YouTube and LinkedIn.
Forward-Looking Statement of Merck & Co., Inc.,
Kenilworth, N.J., USA.
This news release of Merck & Co., Inc., Kenilworth, N.J.,
USA (the “company”) includes “forward-looking statements” within
the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These statements are
based upon the current beliefs and expectations of the company’s
management and are subject to significant risks and uncertainties.
There can be no guarantees with respect to pipeline candidates that
the candidates will receive the necessary regulatory approvals or
that they will prove to be commercially successful. If underlying
assumptions prove inaccurate or risks or uncertainties materialize,
actual results may differ materially from those set forth in the
forward-looking statements.
Risks and uncertainties include but are not limited to, general
industry conditions and competition; general economic factors,
including interest rate and currency exchange rate fluctuations;
the impact of the global outbreak of novel coronavirus disease
(COVID-19); the impact of pharmaceutical industry regulation and
health care legislation in the United States and internationally;
global trends toward health care cost containment; technological
advances, new products and patents attained by competitors;
challenges inherent in new product development, including obtaining
regulatory approval; the company’s ability to accurately predict
future market conditions; manufacturing difficulties or delays;
financial instability of international economies and sovereign
risk; dependence on the effectiveness of the company’s patents and
other protections for innovative products; and the exposure to
litigation, including patent litigation, and/or regulatory
actions.
The company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information,
future events or otherwise. Additional factors that could cause
results to differ materially from those described in the
forward-looking statements can be found in the company’s 2020
Annual Report on Form 10-K and the company’s other filings with the
Securities and Exchange Commission (SEC) available at the SEC’s
Internet site (www.sec.gov).
Please see the Molnupiravir FDA Letter of Authorization at
https://www.merck.com/eua/Merck-EUA-letter.pdf, Fact Sheet for
Healthcare Providers, including Mandatory Requirements for
Administration of Molnupiravir under Emergency Use Authorization,
at https://www.merck.com/eua/molnupiravir-hcp-fact-sheet.pdf and
Fact Sheet for Patients and Caregivers at
https://www.merck.com/eua/molnupiravir-patient-fact-sheet-english.pdf.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211223005322/en/
Media: Melissa Moody (215) 407-3536
Courtney Ronaldo (908) 740-6132
Ridgeback Media: Chrissy Carvalho Chrissy@goldin.com
Investors: Peter Dannenbaum (908) 740-1037
Raychel Kruper (908) 740-2107
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