Merck (NYSE:MRK), known as MSD outside the United States and
Canada, today announced that the U.S. Food and Drug Administration
(FDA) has accepted for review a new supplemental Biologics License
Application (sBLA) for GARDASIL®9 (Human Papillomavirus
9-valent Vaccine, Recombinant), the company’s 9-valent HPV vaccine.
The application is seeking approval for an expanded age indication
for GARDASIL 9 for use in women and men ages 27 to 45 for the
prevention of certain cancers and diseases caused by the nine human
papillomavirus (HPV) types covered by the vaccine. The FDA has
granted Priority Review to this sBLA and has set a Prescription
Drug User Fee Act (PDUFA), or target action, date of Oct. 6,
2018.
“Women and men ages 27 to 45 continue to be at risk for
acquiring HPV, which can lead to cervical cancer and certain other
HPV-related cancers and diseases,” said Dr. Alain Luxembourg,
director, clinical research, Merck Research Laboratories. “We look
forward to working with the FDA on the review of this application
for GARDASIL 9, which, if approved, would enable more people to
have access to the vaccine.”
GARDASIL 9 is a vaccine indicated in the U.S. in females 9
through 26 years of age for the prevention of cervical, vulvar,
vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45,
52, and 58; pre-cancerous 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 also indicated in males 9 through
26 years of age for the prevention of anal cancer caused by HPV
types 16, 18, 31, 33, 45, 52, and 58; 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 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].
About GARDASIL®9 (Human Papillomavirus 9-valent
Vaccine, Recombinant)
GARDASIL 9 includes the greatest number of HPV types in any
available HPV vaccine. After HPV types 16 and 18, the five
additional HPV types in GARDASIL 9 are the most common cervical
cancer-causing types worldwide. Seven HPV types in GARDASIL 9 (HPV
16, 18, 31, 33, 45, 52 and 58) cause approximately 90 percent of
cervical cancer cases and approximately 80 percent of high-grade
cervical lesions (cervical precancers, defined as CIN 2, CIN 3 and
AIS) worldwide. These seven HPV types also cause 90 percent of
HPV-related vulvar cancers, 85 percent of HPV-related vaginal
cancers, and 90 percent of HPV-related anal cancers. HPV types 6
and 11 cause approximately 90 percent of genital warts cases. In
addition, approximately 50 percent of cases of low-grade cervical
lesions (CIN 1) are caused by the nine HPV types included in the
vaccine.
GARDASIL 9 is approved for use in more than 70 countries.
Important information about GARDASIL 9
GARDASIL 9 does not eliminate the necessity for women to
continue to undergo recommended cervical cancer screening.
Recipients of GARDASIL 9 should not discontinue anal cancer
screening if it has been recommended by a health care
professional.
GARDASIL 9 has not been demonstrated to provide protection
against diseases from vaccine HPV types to which a person has
previously been exposed through sexual activity.
GARDASIL 9 is not a treatment for external genital lesions;
cervical, vulvar, vaginal, and anal cancers; or cervical
intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia
(VIN), vaginal intraepithelial neoplasia (VaIN), or anal
intraepithelial neoplasia (AIN).
Not all vulvar, vaginal, and anal cancers are caused by HPV, and
GARDASIL 9 protects only against those vulvar, vaginal, and anal
cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58.
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.
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
region of the upper arm or in the higher anterolateral area of the
thigh.
- For individuals 9 through 14 years of
age, GARDASIL 9 can be administered using a2-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 at0, 2
months, and 6 months.
- For individuals 15 through 26 years of
age, GARDASIL 9 is administered using a3-dose schedule at 0, 2
months, and 6 months.
About HPV and HPV-related cancers and diseases
In the United States, human papillomavirus (HPV) will infect
most sexually active males and females in their lifetime. According
to the CDC, there are approximately 14 million new genital HPV
infections in the United States each year, half of which occur in
people 15 through 24 years of age. For most people, HPV clears on
its own, but for others who don't clear the virus it could lead to
certain cancers and other diseases in males and females. There is
no way to predict who will or won’t clear the virus.
HPV causes virtually all cervical cancer cases. Each day, about
36 women are diagnosed with cervical cancer in the United States --
about 13,200 women per year. HPV also causes approximately 70-75
percent of vaginal cancer cases and approximately 30 percent of
vulvar cancer cases in females, and approximately 85-90 percent of
anal cancers and 90 percent of genital warts in both females and
males.
Anal cancer and genital warts affect both men and women.
According to the American Cancer Society, an estimated 2,960 men
and 5,620 women in the United States will be diagnosed with anal
cancer in 2018, and overall rates have been increasing. There is no
routine screening recommended for the general population to reduce
the risk of anal cancer. Approximately 355,000 cases of genital
warts occur each year in the United States. Approximately 3 out of
4 people get them after having genital contact with someone who has
genital warts.
About Merck
For more than a century, Merck, a leading global
biopharmaceutical company 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.
Through our prescription medicines, vaccines, biologic therapies
and animal health products, we work with customers and operate in
more than 140 countries to deliver innovative health solutions. We
also demonstrate our commitment to increasing access to health care
through far-reaching policies, programs and partnerships. Today,
Merck continues to be at the forefront of research to advance the
prevention and treatment of diseases that threaten people and
communities around the world - including cancer, cardio-metabolic
diseases, emerging animal diseases, Alzheimer's disease and
infectious diseases including HIV and Ebola. 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 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 2017
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 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.
The Patient Product Information for GARDASIL 9 is also
available
at http://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_ppi.pdf.
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MerckMedia:Pamela Eisele, 267-305-3558orDeb Wambold,
267-305-0642orInvestors:Teri Loxam, 908-740-1986orMichael DeCarbo,
908-740-1807
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