GARDASIL®9 (Human Papillomavirus 9-valent
Vaccine, Recombinant) Now Approved for the Prevention of
HPV-Related Cervical, Vaginal, Vulvar, Anal, Oropharyngeal and
Other Head and Neck Cancers
Merck (NYSE: MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has approved an expanded indication for GARDASIL 9 for the
prevention of oropharyngeal and other head and neck cancers caused
by HPV Types 16, 18, 31, 33, 45, 52, and 58. The oropharyngeal and
head and neck cancer indication is approved under accelerated
approval based on effectiveness in preventing HPV-related
anogenital disease. Continued approval for this indication may be
contingent upon verification and description of clinical benefit in
a confirmatory trial. The trial is currently underway.
“At Merck, working to help prevent certain HPV-related cancers
has been a priority for more than two decades,” said Dr. Alain
Luxembourg, director, clinical research, Merck Research
Laboratories. “Today’s approval for the prevention of HPV-related
oropharyngeal and other head and neck cancers represents an
important step in Merck’s mission to help reduce the number of men
and women affected by certain HPV-related cancers.”
GARDASIL 9 is a vaccine indicated in females 9 through 45 years
of age for the prevention of cervical, vulvar, vaginal, anal,
oropharyngeal and other head and neck cancers caused by human
papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58;
cervical, vulvar, vaginal, and anal precancerous or dysplastic
lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58;
and genital warts caused by HPV Types 6 and 11.
GARDASIL 9 is indicated in males 9 through 45 years of age for
the prevention of anal, oropharyngeal and other head and neck
cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal
precancerous or dysplastic lesions caused by HPV Types 6, 11, 16,
18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6
and 11.
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
is contraindicated in individuals with hypersensitivity, including
severe allergic reactions to yeast, or after a previous dose of
GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types
6, 11, 16, and 18) Vaccine, Recombinant].
Both men and women can be at risk for HPV-attributable
oropharyngeal cancer; however, this cancer affects men five times
more than women.1 For most people, HPV clears on its own. But, for
those who don't clear the virus, it can cause certain cancers.
Oropharyngeal cancer can arise as a result of HPV infection in the
oropharynx, which includes the soft palate, side and back wall of
the throat, tonsils, and back one-third of the tongue. According to
a recent model published by the U.S. Centers for Disease Control
and Prevention (CDC), HPV-attributable oropharyngeal cancer has
surpassed cervical cancer as the most prevalent type of HPV-related
cancer in the U.S.1
1 The CDC analyzed data from the U.S. Cancer Statistics (USCS)
to assess the incidence of HPV-associated cancers and to estimate
the annual number of cancers caused by HPV, overall and by state,
during 2012 to 2016.
The estimated number of HPV-attributable cancers was calculated
by multiplying the average number of HPV-associated cancers by the
percentage of HPV-attributable cancers diagnosed from 1993 to 2005,
before HPV vaccination was available in the U.S.
The detection of HPV DNA in an HPV study is not enough to
determine that HPV caused the cancer.
Not all cervical and oropharyngeal cancers are caused by
HPV.
Important Information About GARDASIL 9
GARDASIL 9 does not eliminate the necessity for vaccine
recipients to undergo screening for cervical, vulvar, vaginal,
anal, oropharyngeal and other head and neck cancers as recommended
by a healthcare provider.
GARDASIL 9 has not been demonstrated to provide protection
against diseases caused by:
- HPV types not covered by the vaccine
- HPV types to which a person has previously been exposed through
sexual activity
Not all vulvar, vaginal, anal, oropharyngeal and other head and
neck cancers are caused by HPV, and GARDASIL 9 protects only
against those vulvar, vaginal, anal, oropharyngeal and other head
and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and
58.
GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)
is not a treatment for external genital lesions; cervical, vulvar,
vaginal, anal, oropharyngeal and other head and neck cancers; or
cervical intraepithelial neoplasia (CIN), vulvar intraepithelial
neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal
intraepithelial neoplasia (AIN).
Vaccination with GARDASIL 9 may not result in protection in all
vaccine recipients.
Select Safety Information for GARDASIL 9
GARDASIL 9 is contraindicated in individuals with
hypersensitivity, including severe allergic reactions to yeast, or
after a previous dose of GARDASIL 9 or GARDASIL® [Human
Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine,
Recombinant].
Because vaccinees may develop syncope, sometimes resulting in
falling with injury, observation for 15 minutes after
administration is recommended. Syncope, sometimes associated with
tonic-clonic movements and other seizure-like activity, has been
reported following HPV vaccination. When syncope is associated with
tonic-clonic movements, the activity is usually transient and
typically responds to restoring cerebral perfusion.
Safety and effectiveness of GARDASIL 9 have not been established
in pregnant women.
The most common (≥10%) local and systemic adverse reactions in
females were injection-site pain, swelling, erythema, and headache.
The most common (≥10%) local and systemic reactions in males were
injection-site pain, swelling, and erythema.
The duration of immunity of GARDASIL 9 has not been
established.
Dosage and Administration for GARDASIL 9
GARDASIL 9 should be administered intramuscularly in the deltoid
or anterolateral area of the thigh.
- For individuals 9 through 14 years of age, GARDASIL 9 can be
administered using a 2-dose or 3-dose schedule. For the 2-dose
schedule, the second dose should be administered 6-12 months after
the first dose. If the second dose is administered less than 5
months after the first dose, a third dose should be given at least
4 months after the second dose. For the 3-dose schedule, GARDASIL 9
should be administered at 0, 2 months, and 6 months.
- For individuals 15 through 45 years of age, GARDASIL 9 is
administered using a 3-dose schedule at 0, 2 months, and 6
months.
About HPV and HPV-related Cancers and Diseases
According to the CDC, an estimated 14 million new HPV infections
occur every year in the United States. HPV is so common that 80% of
people who are sexually active get HPV at some point in their life.
For most people, HPV clears on its own; but for those who don’t
clear the virus, it could cause certain cancers and diseases. There
is no way to know which people who have HPV will develop cancer or
other health problems. GARDASIL®9 (Human Papillomavirus 9-valent
Vaccine, Recombinant) helps protect against seven HPV types that
cause the majority of HPV-related cancers in the United States.
Persistent HPV infection can also lead to pre-cancerous lesions
that may require additional follow-up procedures. With the
exception of cervical cancer, there is no routinely recommended
screening for the detection of HPV-related cancers.
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).
Please see the Prescribing Information for GARDASIL®9 (Human
Papillomavirus 9-valent Vaccine, Recombinant) at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf
and the Patient Information for GARDASIL 9 at
http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.
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