If approved by the European Commission,
WINREVAIR will be the first activin signaling inhibitor therapy for
PAH in Europe, offering a new treatment option for certain adults
with this rare, progressive disease
Milestone highlights Merck’s focus on global
filings to expand access to WINREVAIR and commitment to patients
living with PAH
Merck (NYSE: MRK), known as MSD outside of the United States and
Canada, announced today that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA)
recommended the approval of WINREVAIR™ (sotatercept), in
combination with other pulmonary arterial hypertension (PAH)
therapies, for the treatment of PAH in adult patients with World
Health Organization (WHO) Functional Class (FC) II to III, to
improve exercise capacity. WINREVAIR was previously granted
Priority Medicines (PRIME) and orphan designation by the EMA for
the treatment of PAH. The European Commission (EC) will now review
the CHMP recommendation, and the EC’s decision on the marketing
authorization application of WINREVAIR in the EU, Iceland,
Liechtenstein and Norway is expected in the third quarter of
2024.
“PAH is a progressive and debilitating rare disease,” said Dr.
Joerg Koglin, senior vice president and head of general medicine,
global clinical development, Merck Research Laboratories. “There is
still a significant need for new therapies for patients. This
positive opinion marks the first step toward expanding access to
our first-in-class activin signaling inhibitor therapy, WINREVAIR,
for eligible adults with PAH in Europe. We are pleased with the
CHMP recommendation and look forward to the European Commission’s
decision.”
WINREVAIR is administered once every 3 weeks as a single
injection under the skin and may be administered by patients or
caregivers with guidance, training and follow-up from a healthcare
provider.
The CHMP recommendation is based on data from the Phase 3
STELLAR trial of WINREVAIR on top of background PAH therapy
compared to background therapy alone. WINREVAIR demonstrated a
statistically significant and clinically meaningful improvement in
6-minute walk distance, the study’s primary endpoint, and on
multiple important secondary outcome measures, including reducing
the risk of death from any cause or PAH clinical worsening events.
These results were published in The New England Journal of
Medicine.
“WINREVAIR is the first activin signaling inhibitor therapy and
is proposed to modulate the vascular proliferation underlying PAH,”
said Dr. Marius Hoeper, Hannover Medical School, Germany. “Based on
the clinical benefits demonstrated in primary and secondary outcome
measures in the Phase 3 STELLAR study, WINREVAIR has the potential
to play a critical role in the treatment of appropriate adults with
PAH. It is very encouraging that physicians in Europe may soon have
a novel treatment option available that targets a new PAH treatment
pathway.”
Through the CHMP recommendation, the EMA is the second
regulatory body to recognize the potential of WINREVAIR in the
treatment of PAH based on a review of pivotal efficacy and safety
data. In March 2024, WINREVAIR (sotatercept-csrk) was approved by
the U.S. Food and Drug Administration (FDA).
About STELLAR
The STELLAR study (NCT04576988) was a global, double-blind,
placebo-controlled, multicenter, parallel-group clinical trial in
which 323 patients with PAH (WHO Group 1 FC II or III) were
randomized 1:1 to WINREVAIR (target dose 0.7 mg/kg) (n=163) or
placebo (n=160) plus stable background therapy administered
subcutaneously once every 3 weeks.
The most common PAH etiologies were idiopathic PAH (59%),
heritable PAH (18%), and PAH associated with connective tissue
diseases (CTD) (15%). Most participants were receiving either three
(61%) or two (35%) background drugs for PAH, and 40% were receiving
prostacyclin infusions. The mean time from PAH diagnosis was 8.8
years. Patients had a WHO FC II (49%) or III (51%) at baseline.
About WINREVAIR™ (sotatercept-csrk) for injection, for
subcutaneous use, 45 mg, 60 mg
In the U.S., WINREVAIR is FDA-approved for the treatment of
adults with pulmonary arterial hypertension (PAH, WHO Group 1) to
increase exercise capacity, improve WHO functional class (FC) and
reduce the risk of clinical worsening events. WINREVAIR, the first
activin signaling inhibitor therapy approved to treat PAH, improves
the balance between pro-proliferative and anti-proliferative
signaling to modulate vascular proliferation. In preclinical
models, WINREVAIR induced cellular changes that were associated
with thinner vessel walls, partial reversal of right ventricular
remodeling, and improved hemodynamics.
WINREVAIR is the subject of a licensing agreement with Bristol
Myers Squibb.
Selected Safety Information for WINREVAIR in the U.S.
WINREVAIR may increase hemoglobin and lead to erythrocytosis.
Severe erythrocytosis may increase the risk of thromboembolic
events or hyperviscosity syndrome. Monitor Hgb before each dose for
the first 5 doses, or longer if values are unstable, and
periodically thereafter, to determine if dose adjustments are
required.
WINREVAIR may decrease platelet count and lead to severe
thrombocytopenia, which may increase the risk of bleeding;
thrombocytopenia occurred more frequently in patients also
receiving prostacyclin infusion. Do not initiate treatment if
platelet count is <50,000/mm3. Monitor platelets before each
dose for the first 5 doses, or longer if values are unstable, and
periodically thereafter to determine if dose adjustments are
required.
In clinical studies, serious bleeding (e.g., gastrointestinal,
intracranial hemorrhage) was reported in 4% of patients taking
WINREVAIR and 1% of patients taking placebo. Serious bleeding was
more likely in patients on prostacyclin background therapy and/or
antithrombotic agents, or with low platelet counts. Advise patients
about signs and symptoms of blood loss. Do not administer WINREVAIR
if the patient is experiencing serious bleeding.
WINREVAIR may cause fetal harm when administered to a pregnant
woman. Advise pregnant women of the potential risk to a fetus.
Advise females of reproductive potential to use an effective method
of contraception during treatment with WINREVAIR and for at least 4
months after the final dose. Pregnancy testing is recommended for
females of reproductive potential before starting WINREVAIR
treatment.
Based on findings in animals, WINREVAIR may impair female and
male fertility. Advise patients on the potential effects on
fertility.
The most common adverse reactions occurring in the Phase 3
clinical trial (≥10% for WINREVAIR and at least 5% more than
placebo) were headache (24.5% vs 17.5%), epistaxis (22.1% vs 1.9%),
rash (20.2% vs 8.1%), telangiectasia (16.6% vs 4.4%), diarrhea
(15.3% vs 10.0%), dizziness (14.7% vs 6.2%), and erythema (13.5% vs
3.1%).
Because of the potential for serious adverse reactions in the
breastfed child, advise patients that breastfeeding is not
recommended during treatment with WINREVAIR, and for 4 months after
the final dose.
About pulmonary arterial hypertension (PAH)
Pulmonary arterial hypertension (PAH) is a rare, progressive and
life-threatening blood vessel disorder characterized by the
constriction of small pulmonary arteries and elevated blood
pressure in the pulmonary circulation. Approximately 40,000 people
in the U.S. and 30,000 people in the EU are living with PAH. The
disease progresses rapidly for many patients. PAH results in
significant strain on the heart, leading to limited physical
activity, heart failure and reduced life expectancy. The five-year
mortality rate for patients with PAH is approximately 43%, based on
data from the REVEAL registry (patients enrolled between March 2006
and December 2009).
About Merck
At Merck, known as MSD outside of the United States and Canada,
we are unified around our purpose: We use the power of leading-edge
science to save and improve lives around the world. For more than
130 years, we have brought hope to humanity through the development
of important medicines and vaccines. We aspire to be the premier
research-intensive biopharmaceutical company in the world – and
today, we are at the forefront of research to deliver innovative
health solutions that advance the prevention and treatment of
diseases in people and animals. We foster a diverse and inclusive
global workforce and operate responsibly every day to enable a
safe, sustainable and healthy future for all people and
communities. For more information, visit www.merck.com and connect
with us on X (formerly Twitter), Facebook, Instagram, YouTube and
LinkedIn.
Forward-Looking Statement of Merck & Co., Inc., Rahway,
N.J., USA
This news release of Merck & Co., Inc., Rahway, 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 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 Annual
Report on Form 10-K for the year ended December 31, 2023 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 Prescribing Information for WINREVAIR
(sotatercept-csrk) at
http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf,
Patient Information for WINREVAIR at
http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf,
and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit)
at
https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.
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Merck (NYSE:MRK)
過去 株価チャート
から 8 2024 まで 9 2024
Merck (NYSE:MRK)
過去 株価チャート
から 9 2023 まで 9 2024