FDA approves the Novartis quadrivalent meningococcal conjugate vaccine, Menveo®, for use in children from 2 years of age
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Novartis International AG /
FDA approves the Novartis quadrivalent meningococcal conjugate vaccine, Menveo®,
for use in children from 2 years of age
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The issuer is solely responsible for the content of this announcement.
* Expanded age indication of Menveo offers new option to help protect young
children from 2 to 10 years of age against potentially devastating
meningococcal disease[1]
* Novartis to resubmit Menveo infant indication within a few months
Basel, January 31, 2010 - Novartis announced today that it received approval
from the US Food and Drug Administration (FDA) for the use of Menveo(®)
(Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM(197)
Conjugate Vaccine) for active immunization to prevent invasive meningococcal
disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in
individuals 2 to 10 years of age[1]. Menveo received initial FDA approval in
2010 for use in adolescents and adults from 11 to 55 years of age[1].
The FDA approval of Menveo for use in children 2 to 10 years of age is based on
Phase III trial data involving 5,297 participants in that age group. In the
pivotal trial, the safety and immunogenicity of Menveo against each of the four
serogroups were compared with those of the other currently US-licensed ACW-135Y
meningococcal conjugate vaccine[1]. Novartis also agreed to conduct three post
marketing studies.
Separately, Novartis received a Refuse To File (RTF) letter from the FDA
regarding the Company's supplemental Biologics License Application (sBLA) for
the use of Menveo in infants from 2 to 12 months. The sBLA had been submitted to
the FDA in November 2010. Novartis plans to resubmit a sBLA in 2011 for the
expanded use of Menveo in infants and toddlers from 2 months to 2 years old.
"The approval of Menveo for the use in children 2-10 years of age is another
important step towards our goal to protect people of all ages against this
devastating disease," said Andrin Oswald, Division Head of Novartis Vaccines and
Diagnostics. "The response from the FDA on our Menveo infant file is
disappointing. We believe that concerns raised are of procedural nature and plan
to resubmit the sBLA within the next few months. This will also provide us with
an opportunity to supplement the file with additional clinical data that support
expanded use of Menveo in infants and toddlers from 2 months to 2 years old."
About Menveo
As of January 2011, Menveo is registered in more than 40 countries for active
immunization to prevent invasive meningococcal disease caused by Neisseria
meningitidis serogroups A, C, W-135 and Y in people from 11 years of age. Menveo
has been administered to more than 18,500 participants in clinical trials across
all age groups worldwide, and studies are ongoing in infants, toddlers,
adolescents and adults[2]. Menveo received initial FDA licensure in May 2010 for
use in adolescents and adults (11 to 55 years of age)[1]. Pivotal phase III data
presented in October 2010 at the 48th Annual Meeting of the Infectious Diseases
Society of America (IDSA) showed that Menveo induced immune responses in a high
percentage of infants against four important meningococcal disease-causing
serogroups (A, C, Y and W-135)[2].
In the EU, Menveo is known as Meningococcal Group A, C, W135 and Y Conjugate
Vaccine. Novartis Vaccines plans to submit additional data to the European
Medicines Agency to support the use of Menveo in infants and children 0 to 10
years of age in the first half of 2011. The label extension for use in children
2 to 10 years of age has already been submitted in Canada[2].
Important Safety Information
Menveo should not be administered to individuals with known hypersensitivity to
any component of Menveo or other meningococcal vaccines, or other vaccines
containing derivatives of Corynebacterium diphtheriae. Because of the risk of
hematoma, Menveo should not be administered to individuals with any bleeding
disorder, such as hemophilia or thrombocytopenia, nor to persons receiving
anticoagulant therapy, unless the potential benefit outweighs the risk of
administration. Menveo should not be administered to people who have an acute
severe febrile illness, although a mild fever of short duration is not a
contraindication. Due to the absence of supporting data, the decision to
administer Menveo to pregnant women should be evaluated according to the risk of
meningococcal infection.
The most common local adverse reactions to Menveo include injection site pain,
erythema, and induration. The most common systemic adverse reactions include
headache, myalgia, malaise, nausea, arthralgia, chills, rash and fever. Some
reactions may be severe.
Vaccination with Menveo may not protect all individuals. Patients who are
immunocompromised or receiving immunosuppressive therapy may have an inadequate
response to vaccination.
Before administering Menveo, please see full Prescribing Information.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "potentially," "plans," "goal," "plan," "can,"
"potential," or similar expressions, or by express or implied discussions
regarding potential submissions, resubmissions or approvals for new indications
or labeling for Menveo, or the timing of any such submissions, resubmissions or
approvals, 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 submitted, resubmitted or approved for any
additional indications or labeling in any market, or that any such submissions,
resubmissions or approvals will occur 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, including any unexpected inability to satisfy
any conditions imposed by the government with respect to the resubmission of the
infant indication in the US; 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 healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2010, the Group's continuing operations achieved net sales of
USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding
impairment and amortization charges) was invested in R&D throughout the Group.
Headquartered in Basel, Switzerland, Novartis Group companies employ
approximately 119,000 full-time-equivalent associates (including 16,700 Alcon
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.
References
[1] Novartis. Menveo(®)Full Prescribing Information. January 2011.
[2] Novartis Data on File.
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Novartis International AG
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Datum: 31.01.2011 - 07:16 Uhr
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