Merck (NYSE: MRK), known as MSD outside the United States and
Canada, and Ridgeback Biotherapeutics today provided the following
statement at the conclusion of the U.S. Food and Drug
Administration’s (FDA) Antimicrobial Drugs Advisory Committee
(AMDAC) regarding the Emergency Use Authorization (EUA) application
for molnupiravir (MK-4482, EIDD-2801), an investigational oral
antiviral medicine, for the treatment of mild to moderate COVID-19
in adults with positive results of direct SARS-CoV-2 viral testing
who are at high risk for progressing to severe COVID-19 and/or
hospitalization. The Advisory Committee voted 13-10 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.
The FDA is not bound by the committee’s guidance but takes its
advice into consideration.
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“The positive outcome of today’s FDA Advisory Committee meeting,
following a comprehensive review of molnupiravir, including the
compelling data from the MOVe-OUT study demonstrating a significant
reduction in hospitalizations and deaths, is a critical step toward
bringing this promising oral medicine for COVID-19 to appropriate
patients in the U.S. With the continued spread of the virus and the
emergence of variants, additional treatments for COVID-19 are
urgently needed. That is why we are moving with speed and rigor to
pursue authorizations and to accelerate broad global access to this
investigational medicine,” said Dr. Dean Y. Li, executive vice
president and president, Merck Research Laboratories. “We are
grateful to the members of the Advisory Committee who reviewed our
application, as well as to the patients and investigators who
participated in our clinical trials, and we will continue to work
with the FDA as the agency completes its review.”
“We are one step closer to being able to add molnupiravir to the
tools that we have – in addition to vaccines – that can be
available and accessible to help fight COVID-19. Importantly, our
data show activity against the most prevalent variants today, and
molnupiravir was studied as a monotherapy with no drug-drug
interactions observed to date. We will continue to work with
urgency to bring this investigational medicine forward to
appropriate patients,” said Wendy Holman, chief executive officer,
Ridgeback Biotherapeutics.
Under an EUA, to help strengthen the nation’s protection against
public health threats, such as SARS-CoV-2, the FDA may authorize
unapproved medical products or unapproved uses of approved medical
products in a public health emergency to diagnose, treat, or
prevent serious or life-threatening diseases or conditions when
certain criteria are met, including when there are no adequate,
approved, and available alternatives. The AMDAC provides the FDA
with independent, expert advice and recommendations for
consideration in making final decisions, including decisions
related to authorization.
Merck’s submission to the FDA for EUA, as discussed by the
AMDAC, is based on the positive results from a planned interim
analysis of the Phase 3 MOVe-OUT clinical trial and the recent
study update, including data from all randomized patients. MOVe-OUT
evaluated molnupiravir in non-hospitalized adult patients with mild
to moderate COVID-19 with symptom onset within five days prior to
randomization who were at high risk for progressing to severe
COVID-19 and/or hospitalization. At the planned interim analysis,
which based on the study design was the primary efficacy analysis
of the study, 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 who were hospitalized; at the interim analysis, no
patients who took molnupiravir died, compared to eight patients who
received placebo. The absolute risk reduction between the
molnupiravir and the placebo arm was 6.8 percentage points (95%
confidence interval [CI]: 2.4, 11.3; p=0.0012), which is
approximately a 50% reduction in the risk of hospitalization or
death through Day 29 compared with placebo. The efficacy benefit
with molnupiravir treatment was consistent across important patient
subgroups, including patients infected with SARS-CoV-2 variants of
concern, Delta, Gamma and Mu.
On Nov. 26, Merck announced additional analyses from all
enrolled participants (n=1433). In this population, molnupiravir
reduced the risk of hospitalization or death from 9.7% in the
placebo group (68/699) to 6.8% (48/709) in the molnupiravir group,
for an absolute risk reduction of 3.0% (95% CI: 0.1, 5.9; nominal
p-value=0.0218) and a relative risk reduction of 30% (relative risk
0.70; 95% CI: 0.49, 0.99). Nine deaths were reported in the placebo
group, and one in the molnupiravir group.
At the planned interim analysis, the incidence of any adverse
event (AE) was comparable in the molnupiravir and placebo groups
(35.0% and 39.6%, respectively). The incidence of drug-related AEs
was also comparable (12.4% and 11.1%, respectively). Fewer subjects
discontinued study therapy due to an AE in the molnupiravir group
(1.3%) compared to the placebo group (3.4%). In the supportive
analysis of all randomized patients, the AE profile for
molnupiravir remained consistent with the profile reported at the
planned interim analysis.
About Molnupiravir
Molnupiravir (MK-4482 and EIDD-2801) is an investigational,
orally administered form of a potent ribonucleoside analog that
inhibits the replication of SARS-CoV-2, the causative agent of
COVID-19. Molnupiravir has been shown to be active in several
preclinical models of SARS-CoV-2, including for prophylaxis,
treatment, and prevention of transmission. Pre-clinical data
suggest that molnupiravir has a high barrier to the development of
resistance.
Molnupiravir is being studied as a single medicine, without the
use of concomitant medicines and without food intake restrictions
or dose modifications based on renal or hepatic impairment. Based
on available data, no known drug interactions with molnupiravir
have been identified.
Molnupiravir was invented at Drug Innovations at Emory (DRIVE),
LLC, a not-for-profit biotechnology company wholly owned by Emory
University; 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 & Co., Inc. 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.
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. For more information, please visit
http://merckcovidresearch.com.
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 EUA or approval from the U.S. FDA. Merck has
entered into advance purchase and supply agreements for
molnupiravir with the governments of multiple countries worldwide,
including Thailand, Korea, Japan, 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.
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.
About the MOVe-OUT Study
The MOVe-OUT trial (MK-4482-002) (NCT04575597) was a global
Phase 3, randomized, placebo-controlled, double-blind, multi-site
study of non-hospitalized adult patients with laboratory-confirmed
mild to moderate COVID-19. Patients enrolled in the study were
unvaccinated against SARS-CoV-2, had at least one risk factor
associated with poor disease outcomes, and symptom onset within
five days prior to randomization. The primary efficacy objective of
MOVe-OUT is to evaluate the efficacy of molnupiravir 800 mg twice
daily for five days compared to placebo as assessed by the
percentage of participants who are hospitalized and/or die from the
time of randomization through Day 29.
The Phase 3 portion of the MOVe-OUT trial was conducted
globally, including in more than 170 planned sites in countries
including Argentina, Brazil, Canada, Chile, Colombia, Egypt,
France, Germany, Guatemala, Israel, Italy, Japan, Mexico,
Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan,
Ukraine, the United Kingdom and the United States. For further
information about the MOVe-OUT trial, please visit
clinicaltrials.gov.
The most common risk factors for poor disease outcome included
obesity, older age (>60 years), diabetes mellitus and heart
disease. Delta, Gamma and Mu variants accounted for the vast
majority of the baseline viral variants that had been sequenced at
the time of the interim analysis.
About Ridgeback Biotherapeutics
Headquartered in Miami, Florida, Ridgeback Biotherapeutics LP is
a biotechnology company focused on emerging infectious diseases.
Ridgeback markets EbangaTM 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).
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Media Contacts: Melissa Moody (215) 407-3536 Patrick Ryan (973)
275-7075 Ridgeback Media Contact: Chrissy Carvalho
Chrissy@goldin.com Investor Contacts: Peter Dannenbaum (908)
740-1037 Raychel Kruper (908) 740-2107
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