NEW YORK--(BUSINESS WIRE)--
Pfizer Inc. (NYSE: PFE)
today announced that TRUMENBA® (Meningococcal Group B
Vaccine) received Breakthrough Therapy designation from the U.S. Food
and Drug Administration (FDA) for active immunization to prevent
invasive disease caused by Neisseria meningitidis group B (MenB)
in children ages 1 through 9 years. This is the first Breakthrough
Therapy designation for a MenB vaccine to help protect children as young
as 1 year of age. TRUMENBA previously received Breakthrough Therapy
designation in 2014 for the prevention of MenB in adolescents and young
adults ages 10 through 25 years, and later the same year received FDA
approval as the first MenB vaccine approved in the U.S.
As noted in the October 2014 Approval Letter, Pfizer was required to
assess the safety and effectiveness of TRUMENBA in children down to 1
year of age. Pfizer has successfully completed Phase 2 studies in this
investigational age group and these data have been submitted to the FDA.
These data supported Pfizer’s request for Breakthrough Therapy
designation.
“Despite the occurrence of invasive serogroup B disease in children ages
1 through 9 years, and the potential life-altering and long-term
consequences that may result from this uncommon disease, there is no
MenB vaccine licensed in the U.S. for this age group,” said Dr. Luis
Jodar, Chief Medical and Scientific Affairs Officer, Vaccines Medical
Development, Scientific and Clinical Affairs, Pfizer Inc. “We look
forward to working closely with the FDA toward our goal to extend the
range of individuals who may benefit from immunization with TRUMENBA.”
In April 2017, TRUMENBA received traditional approval from the FDA in
individuals 10 to 25 years of age for the three-dose schedule based on
Phase 3 data, making it the only MenB vaccine in the U.S. with this full
approval. TRUMENBA can be administered as a two‐ or three‐dose schedule
to adolescents and young adults 10 through 25 years of age depending on
an individual’s risk of exposure and susceptibility to MenB. A study to
confirm the effectiveness of the two-dose schedule is ongoing.
The majority of invasive meningococcal disease cases worldwide can be
attributed to six Neisseria meningitidis serogroups (A, B, C, W,
X, and Y). Together, serogroups A, B, C, W, and Y account for 90% of all
invasive meningococcal disease (IMD)1, with MenB accounting
for the majority of disease in adolescents and young adults in the U.S.
and Europe.2 As of 2016, the burden of MenB is highest in
adolescents/young adults (32%) and infants (20%), followed by children
ages 1 to 4 years (12%) and children ages 5 to 10 years (4%).3
Breakthrough Therapy designation was initiated as part of the Food and
Drug Administration Safety and Innovation Act (FDASIA) signed in 2012.
As defined by the FDA, a breakthrough therapy is a drug intended to be
used alone or in combination with one or more other drugs to treat a
serious or life-threatening disease or condition and preliminary
clinical evidence indicates that the drug may demonstrate substantial
improvement over existing therapies on one or more clinically
significant endpoints, such as substantial treatment effects observed
early in clinical development. If a drug is designated as a breakthrough
therapy, the FDA may expedite the development and review of such drug.4
U.S. Indication for TRUMENBA® (Meningococcal
Group B Vaccine)
TRUMENBA is a vaccine indicated for individuals 10 through 25 years of
age for active immunization to prevent invasive disease caused by Neisseria
meningitidis (N meningitidis) group B. The effectiveness of
the two-dose schedule of TRUMENBA against diverse N meningitidis
group B strains has not been confirmed.
IMPORTANT SAFETY INFORMATION
TRUMENBA should not be given to anyone with a history of a severe
allergic reaction after a previous dose of TRUMENBA. Some individuals
with weakened immune systems may have a reduced immune response.
As with any vaccine, vaccination with TRUMENBA may not protect all
vaccine recipients against N meningitidis group B infections.
The most common adverse reactions in adolescents and young adults were
pain at injection site, fatigue, headache, and muscle pain. Nausea was
reported in adolescents in early phase studies.
Data are not available on the safety and effectiveness of using TRUMENBA
and other meningococcal group B vaccines interchangeably to complete the
vaccination series.
Tell your health care provider if you are pregnant, or plan to become
pregnant. Ask your health care provider about the risks and benefits of
TRUMENBA. Only a health care provider can decide if TRUMENBA is right
for you or your child.
You are encouraged to report negative side effects of vaccines to
the U.S. Food and Drug Administration (FDA) and the Centers for Disease
Control and Prevention (CDC). Visit www.vaers.hhs.gov
or call 1-800-822-7967.
For the full prescribing information for TRUMENBA, please visit http://labeling.pfizer.com/ShowLabeling.aspx?id=1796.
About TRUMENBA® (Meningococcal Group B
Vaccine)
TRUMENBA® (Meningococcal Group B Vaccine) is a sterile
suspension composed of two recombinant lipidated factor H binding
protein (fHBP) variants from N meningitidis serogroup B, one
from fHBP subfamily A and one from subfamily B (A05 and B01,
respectively). fHBP is one of many proteins found on the surface of
meningococci and contributes to the ability of the bacterium to avoid
host defenses. fHBPs can be categorized into two immunologically
distinct subfamilies, A and B. The susceptibility of serogroup B
meningococci to complement‐mediated, antibody‐dependent killing
following vaccination with TRUMENBA is dependent on both the antigenic
similarity of the bacterial and vaccine fHBPs, as well as the amount of
fHBP expressed on the surface of the invading meningococci.5
As with any vaccine, TRUMENBA may not prevent disease in all vaccinated
individuals. The frequency of meningococcal disease caused by serogroup
B varies geographically, and could influence the ability to evaluate
effectiveness of the vaccine in any given country. Based on the low
incidence of meningococcal disease, placebo‐controlled clinical trials
for TRUMENBA were considered unfeasible due to the size of the study
that would be required and were not performed. Licensure of TRUMENBA was
based on demonstration of immune responses measured using a serum
bactericidal assay with human complement (hSBA).
Pfizer Inc: Working together for a healthier world™
At Pfizer, we apply science and our global resources to bring therapies
to people that extend and significantly improve their lives. We strive
to set the standard for quality, safety and value in the discovery,
development and manufacture of health care products. Our global
portfolio includes medicines and vaccines as well as many of the world's
best‐known consumer health care products. Every day, Pfizer colleagues
work across developed and emerging markets to advance wellness,
prevention, treatments and cures that challenge the most feared diseases
of our time. Consistent with our responsibility as one of the world's
premier innovative biopharmaceutical companies, we collaborate with
health care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world. For
more than 150 years, we have worked to make a difference for all who
rely on us. We routinely post information that may be important to
investors on our website at www.pfizer.com.
In addition, to learn more, please visit us on www.pfizer.com
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DISCLOSURE NOTICE: The information contained in this release
is as of April 23, 2018. Pfizer assumes no obligation to update forward‐looking
statements contained in this release as the result of new information or
future events or developments.
This release contains forward‐looking information about
TRUMENBA® (Meningococcal Group B Vaccine) and a
potential expanded indication to prevent invasive disease caused by MenB
in children ages 1 through 9 years, including its potential benefits,
that involves substantial risks and uncertainties that could cause
actual results to differ materially from those expressed or implied by
such statements. Risks and uncertainties include, among other things,
uncertainties regarding the ability to obtain recommendations from
vaccine technical committees and other public health authorities
regarding TRUMENBA and uncertainties regarding the commercial impact of
any such recommendations; uncertainties regarding the commercial success
of TRUMENBA; the uncertainties inherent in research and development,
including the ability to meet anticipated clinical trial completion
dates and regulatory submission dates, as well as the possibility of
unfavorable clinical trial results, including unfavorable new clinical
data or additional analyses of existing clinical data; the risk that
clinical trial data are subject to differing interpretations, and, even
when we view data as sufficient to support the safety and/or
effectiveness of a product candidate, regulatory authorities may not
share our views and may require additional data or may deny approval
altogether; whether regulatory authorities will be satisfied with the
design of and results from our clinical studies; whether and when any
supplemental biologics license applications may be filed in any
jurisdictions for the potential expanded indication for TRUMENBA or in
any other jurisdictions for any other potential indications for
TRUMENBA; whether and when any such applications may be approved by
regulatory authorities, which will depend on the assessment by such
regulatory authorities of the benefit-risk profile suggested by the
totality of the immunogenicity and safety information submitted and, if
approved, whether TRUMENBA will be commercially successful; decisions by
regulatory authorities regarding labeling and other matters that could
affect the availability or commercial potential of TRUMENBA, including
the potential expanded indication; and competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10‐K for the fiscal year ended
December 31, 2017 and in its subsequent reports on Form 10‐Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results,” as well as in its subsequent reports on Form 8‐K, all
of which are filed with the U.S. Securities and Exchange Commission and
available at www.sec.gov
and www.pfizer.com.
_____________________
1 Kieny MP, Excier J, Girard M.
Research and development of new vaccines against infectious diseases. Am
J Public Health. 2004;94(11):1931-1935.
2 Soeters
HM, McNamara LA, Whaley M, Wang X, Alexander-Scott N, Kanadanian, KV, et
al. Serogroup B meningococcal disease outbreak and carriage evaluation
at a college – Rhode Island, 2015. MMWR Morb Mortal Wkly Rep.
2015;64(22):606-607.
3 US CDC Enhanced Meningococcal
Disease Surveillance Report, 2016. Available at: https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report.pdf
4
Food and Drug Administration Fact Sheet Breakthrough Therapies at https://www.fda.gov/RegulatoryInformation/LawsEnforcedbyFDA/SignificantAmendmentstotheFDCAct/FDASIA/ucm329491.htm
5
TRUMENBA (meningococcal group B vaccine) prescribing information.
Philadelphia, PA: Pfizer, Inc. 2017.
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Source: Pfizer Inc.