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Novartis
announced today that the US Food and Drug
Administration (FDA) approved Menveo^® (Meningococcal Group A, C, W-135 and Y
conjugate vaccine) for the prevention of meningococcal disease caused by four
strains of the bacterium Neisseria meningitidis (N. meningitidis) in infants
and toddlers from 2 months of age[1]. With this expanded indication,
pediatricians in the US can now offer a single vaccine for the protection of
infants, children and adolescents against four of the five most common
serogroups that cause meningococcal disease[1],[5].
"Each year, more children in the US die or are left with permanent disability
from meningococcal disease than from two other diseases combined that we
routinely vaccinate infants against - rotavirus and varicella," said Dr. Steve
Black, Center for Global Health, University of Cincinnati Children's Hospital.
"With the expanded indication for this MCV4 vaccine, we now have the
opportunity to help protect our infants against four strains of meningococcal
disease earlier, when they are most vulnerable."
Infants younger than 7 months old are the most vulnerable age group to
meningococcal disease in the US. In their first year of life, infants are more
than seven times more likely to contract the disease than 14 to 24 year
olds[4]. Of the infants who contract the disease, more than 10 percent will
die from it and of those who do survive, approximately one in every five will
suffer permanent, devastating side effects, including amputations, hearing
loss, paralysis and brain damage[3],[6].
"Despite recommendations for routine immunization of adolescents, college
students living in dormitories and certain infants in the US, meningococcal
disease continues to kill and maim," said Andrin Oswald, Head of Novartis
Vaccines and Diagnostics. "With this approval for the expanded use of Menveo,
we hope that health authorities will deploy this vaccine to further reduce the
burden of this devastating disease in the US."
This FDA approval was based on data from three randomized multicenter studies
involving more than 8,700 infants, conducted in Australia, Canada, Latin
America, Taiwan and the US. The studies demonstrated that Menveo generated a
robust protective immune response and was generally well tolerated when
administered with other routine pediatric vaccines[1].
About Menveo
Menveo is a quadrivalent conjugate vaccine for use to protect against invasive
disease caused by four groups of the bacterium Neisseria meningitidis (A, C, Y
and W-135)[1]. As of July 2013, Menveo is registered in more than 50 countries
for active immunization to prevent invasive meningococcal disease caused by
Neisseria meningitidis serogroups A, C, W-135 and Y[1]. Studies are ongoing in
infants, toddlers, adolescents and adults.
Menveo has been available for use in adolescents and adults (11 to 55 years of
age) since February 2010 and in children (2 to 10 years of age) since January
2011[1],[7].
For more information about Menveo, visit www.menveo.com.
Important Safety Information
Severe allergic reaction (e.g., anaphylaxis) after a previous dose of Menveo,
any component of this vaccine, or any other CRM[197], diphtheria toxoid or
meningococcal-containing vaccine is a contraindication to administration of
Menveo. Appropriate medical treatment must be available should an acute
allergic reaction, including an anaphylactic reaction, occur following
administration of Menveo.
Syncope, sometimes resulting in falling injury associated with seizure-like
movements has been reported following vaccination with Menveo. Vaccinees
should be observed for at least 15 minutes after vaccine administration to
prevent and manage syncopal reactions.
Safety and effectiveness of Menveo have not been evaluated in
immunocompromised persons. If Menveo is administered to immunocompromised
persons, including those receiving immunosuppressive therapy, the expected
immune response may not be obtained.
Guillain-Barré Syndrome (GBS) has been reported in temporal relationship
following administration of another US-licensed meningococcal quadrivalent
polysaccharide conjugate vaccine. The decision to administer Menveo to
subjects with a known history of GBS should take into account the potential
benefits and risks.
Apnea following intramuscular vaccination has been observed in some infants
born prematurely. The decision about when to administer an intramuscular
vaccine, including Menveo, to an infant born prematurely should be based on
consideration of the individual infant's medical status, and the potential
benefits and possible risks of vaccination.
In clinical trials, common solicited adverse reactions with Menveo among
children initiating vaccination at 2 months of age and receiving the four-dose
series were tenderness and erythema at injection site, irritability,
sleepiness, persistent crying, change in eating habits, vomiting and diarrhea.
Common solicited adverse reactions among children initiating vaccination at 7
months through 23 months of age and receiving the two-dose series were
tenderness and erythema at injection site, irritability, sleepiness,
persistent crying, change in eating habits and diarrhea. Common solicited
adverse reactions among children 2 years through 10 years of age were
injection site pain, erythema, irritability, induration, sleepiness, malaise,
and headache. Common solicited adverse reactions among adolescents and adults
were pain at the injection site, headache, myalgia, malaise and nausea. Some
events were severe. Safety has not been established in pregnant women.
Vaccination with Menveo may not protect all individuals.
Before administering Menveo, please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as "can," "opportunity," "hope," "will,"
"potential," "may," or similar expressions, or by express or implied
discussions regarding potential new indications or labeling for Menveo or
regarding potential future revenues from Menveo. You should not place undue
reliance on these statements. Such forward-looking statements reflect the
current views of management regarding future events, and involve known and
unknown risks, uncertainties and other factors that may cause actual results
with Menveo to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Menveo will be approved for any additional indications or
labeling in any market, or at any particular time. Nor can there be any
guarantee that Menveo will achieve any particular levels of revenue in the
future. In particular, management's expectations regarding Menveo could be
affected by, among other things, unexpected regulatory actions or delays or
government regulation generally; unexpected clinical trial results, including
unexpected new clinical data and unexpected additional analysis of existing
clinical data; competition in general; government, industry and general public
pricing pressures; unexpected manufacturing issues; the company's ability to
obtain or maintain patent or other proprietary intellectual property
protection; the impact that the foregoing factors could have on the values
attributed to the Novartis Group's assets and liabilities as recorded in the
Group's consolidated balance sheet, and other risks and factors referred to in
Novartis AG's current Form 20-F on file with the US Securities and Exchange
Commission. Should one or more of these risks or uncertainties materialize, or
should underlying assumptions prove incorrect, actual results may vary
materially from those anticipated, believed, estimated or expected. Novartis
is providing the information in this press release as of this date and does
not undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information, future events
or otherwise.
About Novartis
Novartis provides innovative healthcare solutions that address the evolving
needs of patients and societies. Headquartered in Basel, Switzerland, Novartis
offers a diversified portfolio to best meet these needs: innovative medicines,
eye care, cost-saving generic pharmaceuticals, preventive vaccines and
diagnostic tools, over-the-counter and animal health products. Novartis is the
only global company with leading positions in these areas. In 2012, the Group
achieved net sales of USD 56.7 billion, while R&D throughout the Group
amounted to approximately USD 9.3 billion (USD 9.1 billion excluding
impairment and amortization charges). Novartis Group companies employ
approximately 131,000 full-time-equivalent associates and operate in more than
140 countries around the world. For more information, please visit
http://www.novartis.com.
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