FDA requests additional data on Novartis quadrivalent meningococcal conjugate vaccine, Menveo®, for expanded use in infants and toddlers
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Novartis International AG /
FDA requests additional data on Novartis quadrivalent meningococcal conjugate
vaccine, Menveo®, for expanded use in infants and toddlers
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The issuer is solely responsible for the content of this announcement.
* Agency issues Complete Response letter requesting more information to
support approval
Basel, February 13, 2012 - Novartis has received a Complete Response letter from
the US Food and Drug Administration (FDA) on its application for the expanded
use of Menveo(®) (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide
Diphtheria CRM(197) Conjugate Vaccine) in infants and toddlers from 2 months of
age. Menveo is already approved for use in individuals 2 to 55 years of age in
the US.
Novartis submitted the supplemental Biologics License Application (sBLA) for
Menveo to the FDA in April 2011. The Complete Response letter indicates the FDA
has completed the current review cycle and requests answers to additional
questions prior to proceeding with further review of the sBLA. Novartis will
work with the FDA to address these questions.
About Menveo
As of February 2012, 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. Menveo received the FDA approval for
use in adolescents and adults (11 to 55 years of age) in February 2010 and
approval for use in children 2 to 10 years of age in January 2011. Since launch,
more than 3 million doses of Menveo have been distributed worldwide. Studies are
ongoing in infants, toddlers, adolescents and adults.
Important Safety Information
Menveo is contraindicated in individuals who have experienced a severe allergic
reaction after a previous dose of Menveo, any component of this vaccine, or any
other CRM(197), diphtheria toxoid or meningococcal-containing vaccine.
Appropriate medical treatment must be available should an acute allergic
reaction, including an anaphylactic reaction, occur follow administration of
Menveo.
Those vaccinated may develop syncope, sometimes resulting in falling with injury
associated with seizure-like movements. Observation for 15 minutes after
vaccination is recommended. Patients who are immunocompromised or receiving
immunosuppressive therapy may have an inadequate response to vaccination.
Following vaccination with another US-licensed meningococcal quadrivalent
polysaccharide conjugate vaccine, an evaluation of postmarketing adverse events
suggested a potential for an increased risk of Guillain-Barré syndrome (GBS).
Data are not available to evaluate the potential risk of GBS following
administration of Menveo.
In clinical trials, the most frequently occurring adverse events in subjects 11
to 55 years of age who received Menveo were pain at the injection site,
headache, myalgia, malaise, and nausea. The most frequently occurring adverse
events in subjects 2-10 years of age who received Menveo were pain at the
injection site, erythema, irritability, induration, sleepiness, malaise, and
headache. 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 "will," "potential," 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 regarding the timing of any such approvals. 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 Vaccines and Diagnostics is a division of Novartis, focused on the
development of preventive treatments. The division has two businesses: Novartis
Vaccines and Novartis Diagnostics. Novartis Vaccines is the world's fifth-
largest vaccines manufacturer and second-largest supplier of flu vaccines in the
US. The division's products also include meningococcal, pediatric and travel
vaccines. Novartis Diagnostics, the blood testing business, is dedicated to
preventing the spread of infectious diseases through the development of novel
blood-screening tools that protect the world's blood supply.
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 2011, the Group's
continuing operations achieved net sales of USD 58.6 billion, while
approximately USD 9.6 billion (USD 9.2 billion excluding impairment and
amortization charges) was invested in R&D throughout the Group. Novartis Group
companies employ approximately 124,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visit http://www.novartis.com.
Novartis is on Twitter. Sign up to follow (at)Novartis at
http://twitter.com/novartis.
# # #
Novartis Media Relations
Central media line : +41 61 324 2200
Eric Althoff Julie Masow
Novartis Global Media Relations Novartis Corporate Communications
+41 61 324 7999 (direct) +1 212 830 2465 (direct)
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Novartis Vaccines and Diagnostics
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Pierre-Michel Bringer +41 61 324 1065 Richard Jarvis +1 212 830 2433
Thomas Hungerbuehler +41 61 324 8425 Jill Pozarek +1 212 830 2445
Isabella Zinck +41 61 324 7188 Edwin Valeriano +1 212 830 2456
e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
Media release (PDF):
http://hugin.info/134323/R/1584870/495961.pdf
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Source: Novartis International AG via Thomson Reuters ONE
[HUG#1584870]
Unternehmensinformation / Kurzprofil:
Datum: 13.02.2012 - 07:15 Uhr
Sprache: Deutsch
News-ID 113581
Anzahl Zeichen: 10222
contact information:
Town:
Basel
Kategorie:
Business News
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