Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that the European Medicines Agency’s
Committee for Medicinal Products for Human Use (CHMP) has
recommended the approval of VAXNEUVANCE™ (Pneumococcal 15-valent
Conjugate Vaccine) for active immunization for the prevention of
invasive disease and pneumonia caused by Streptococcus pneumoniae
in individuals 18 years of age and older.
The CHMP recommendation will now be reviewed by the European
Commission for marketing authorization in the European Union, and a
final decision is expected by the end of the year.
The CHMP opinion was based on data from seven randomized,
double-blind clinical studies evaluating VAXNEUVANCE in 7,438
individuals from a variety of adult populations and clinical
circumstances. In July 2021, VAXNEUVANCE received approval from the
U.S. Food and Drug Administration (FDA) for active immunization for
the prevention of invasive disease caused by Streptococcus
pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F,
22F, 23F and 33F in adults 18 years and older.
About Pneumococcal Disease
The global prevalence of pneumococcal disease, an infection
caused by bacteria called Streptococcus pneumoniae, is evolving.
Highly aggressive strains, or serotypes, threaten to put more
people at risk for invasive pneumococcal illnesses such as
bacteremia (infection in the bloodstream); bacteremic pneumonia
(pneumonia with bacteremia); and meningitis (infection of the
coverings of the brain and spinal cord), as well as non-invasive
pneumonia (when pneumococcal disease is confined to the lungs).
While healthy adults can suffer from pneumococcal disease, patient
populations particularly vulnerable to infection include older
adults such as those 65 years of age and older, people with HIV,
and those with certain chronic health conditions.
About VAXNEUVANCE (Pneumococcal 15-valent Conjugate
Vaccine)
VAXNEUVANCE, Merck’s 15-valent pneumococcal conjugate vaccine,
consists of purified capsular polysaccharides from S. pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F
and 33F individually conjugated to CRM197 carrier protein.
VAXNEUVANCE is indicated in the U.S. for active immunization of
adults 18 years of age and older for the prevention of invasive
disease caused by the S. pneumoniae serotypes contained in the
vaccine.
U.S. Select Safety Information for VAXNEUVANCE in Adults 18
Years of Age and Older
Do not administer VAXNEUVANCE to individuals with a severe
allergic reaction (e.g., anaphylaxis) to any component of
VAXNEUVANCE or to diphtheria toxoid.
Some individuals with altered immunocompetence, including those
receiving immunosuppressive therapy, may have a reduced immune
response to VAXNEUVANCE.
The most commonly reported solicited adverse reactions in
individuals 18 through 49 years of age were: injection site pain
(75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%),
injection site swelling (21.7%), injection site erythema (15.1%)
and arthralgia (12.7%).
The most commonly reported solicited adverse reactions in
individuals 50 years of age and older were: injection site pain
(66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%),
injection site swelling (15.4%), injection site erythema (10.9%)
and arthralgia (7.7%).
Vaccination with VAXNEUVANCE may not protect all vaccine
recipients.
Merck’s Commitment to Infectious Diseases
For more than 100 years, Merck has contributed to the discovery
and development of novel medicines and vaccines to combat
infectious diseases. In addition to a combined portfolio of
vaccines and antibacterial, antiviral and antifungal medicines,
Merck has multiple programs that span discovery through late-stage
development. To learn more about Merck’s infectious diseases
pipeline, visit www.merck.com.
About Merck
For over 130 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 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 U.S. Prescribing Information for VAXNEUVANCE
(Pneumococcal 15-valent Conjugate Vaccine) at
https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_pi.pdf
and U.S. Patient Information at
https://www.merck.com/product/usa/pi_circulars/v/vaxneuvance/vaxneuvance_ppi.pdf.
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