Application Based on First Contemporary
Outcomes Study Focused Exclusively on Chronic Heart Failure Patient
Population Following a Worsening Event
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, announced today that the U.S. Food and Drug Administration
(FDA) has accepted for priority review the New Drug Application
(NDA) for vericiguat, an orally administered soluble guanylate
cyclase (sGC) stimulator, to reduce the risk of cardiovascular
death and heart failure hospitalization following a worsening heart
failure event in patients with symptomatic chronic heart failure
with reduced ejection fraction (HFrEF), in combination with other
heart failure therapies. The FDA has set a Prescription Drug User
Fee Act (PDUFA), or target action date, of Jan. 20, 2021.
Vericiguat is being jointly developed with Bayer AG.
“This submission builds on Merck’s commitment to patients with
cardiovascular disease and long legacy of advancing cardiovascular
research to meet unmet medical needs,” said Dr. Roy Baynes, senior
vice president and head of global clinical development, chief
medical officer, Merck Research Laboratories. “We look forward to
working with the FDA as they review this New Drug Application for
vericiguat.”
The application is based on results from the Phase 3 VICTORIA
trial, which is the first contemporary outcomes study focused
exclusively on a population with worsening chronic heart failure
who are at high risk for cardiovascular mortality and repeated
heart failure hospitalizations. Data from VICTORIA were presented
at the virtual American College of Cardiology’s 69th Annual
Scientific Session together with World Congress of Cardiology
(ACC.20/WCC) and published in The New England Journal of
Medicine.
About the VICTORIA Trial
VICTORIA (NCT02861534) is a randomized, placebo-controlled,
parallel-group, multi-center, double-blind, Phase 3 study of
vericiguat versus placebo when given in combination with available
heart failure therapies in patients with worsening chronic heart
failure (New York Heart Association class II-IV), a reduced left
ventricular ejection fraction of <45% within 12 months prior to
randomization following a decompensation event. The primary
endpoint of the study was the composite of time to first occurrence
of heart failure hospitalization or cardiovascular death. Secondary
endpoints included time to occurrence of cardiovascular death, time
to first occurrence of heart failure hospitalization, time to total
heart failure hospitalizations (including first and recurrent
events), time to the composite of all-cause mortality or heart
failure hospitalization, and time to all-cause mortality.
The study enrolled a total of 5,050 patients who were randomly
selected to receive either vericiguat once daily (titrated up to 10
mg) or placebo when given in combination with available heart
failure therapies. The study was co-sponsored by Merck and Bayer,
conducted under the scientific oversight of the Canadian VIGOUR
Centre and the Duke Clinical Research Institute, and executed by
Merck in more than 600 centers in 42 countries including in Europe,
Japan, China and the U.S.
About Heart Failure with Reduced Ejection Fraction
HFrEF, formerly known as systolic heart failure, is
characterized by the compromised ability of the heart to eject
blood sufficiently during its contraction phase. In the U.S., 6.5
million people have heart failure, and approximately 40-50% of
these patients have HFrEF. Annually, approximately 30% of patients
with symptomatic chronic heart failure will experience worsening of
the disease, which is marked by progressive symptoms and/or a
recent heart failure event. Approximately half of patients with
worsening chronic HFrEF are rehospitalized within 30 days of a
worsening event, and an estimated one in five patients with
worsening chronic HFrEF will die within two years.
About the Worldwide Collaboration Between Bayer and
Merck
Since October 2014, Bayer and Merck (known as MSD outside of the
United States and Canada) have pursued a worldwide collaboration in
the field of sGC modulators. The collaboration brings together two
leading companies that have stated their intent to fully evaluate
this therapeutic class in areas of unmet medical need. The
vericiguat program is being co-developed by Bayer and Merck.
About Merck
For more than 125 years, Merck, known as MSD outside of 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 products that
the products 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 recent 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 2019
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).
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200716005203/en/
Media Pamela Eisele, (267) 305-3558 Elizabeth Sell, (267)
305-3877
Investor Peter Dannenbaum, (908) 740-1037 Michael DeCarbo, (908)
740-1807
Merck (NYSE:MRK)
Historical Stock Chart
From Mar 2024 to Apr 2024
Merck (NYSE:MRK)
Historical Stock Chart
From Apr 2023 to Apr 2024