Novartis application for expanded Menveo® indication from 2 months of age accepted for review by FDA
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Novartis application for expanded Menveo® indication from 2 months of age
accepted for review by FDA
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The issuer is solely responsible for the content of this announcement.
* Submission includes data in more than 6,000 infants and toddlers
worldwide[1]
* Protecting infants is critical as they are at highest risk of contracting
meningococcal disease[2]
Basel, June 16, 2011 - Novartis announced today that the US Food and Drug
Administration (FDA) has accepted for review its supplemental Biologics License
Application (sBLA) to expand the Menveo(®) (Meningococcal [Groups A, C, Y and W-
135] Oligosaccharide Diphtheria CRM(197) Conjugate Vaccine) indication to
include infants and toddlers from 2 months of age. Menveo is already approved in
the US for use in individuals 2 years to 55 years of age[3].
The sBLA is supported by data from pivotal trials which included more than
6,000 infants and toddlers worldwide. In the trial measuring the body's immune
response (immunogenicity) to the vaccine one month after completion of a four
dose Menveo series administered at 2, 4, 6 and 12-16 months of age, 100% of
subjects achieved the correlated protection level (hSBA titers >=8) against
serogroups W-135 and Y, and 94% and 98% of subjects achieved this level against
serogroups A and C, respectively[1]. Menveo was generally well tolerated when
administered either alone or with other pediatric vaccines[4].
The application accepted today includes infant data aged 2 to 12 months as well
as additional data that support the use of Menveo in toddlers from 12 to 23
months of age.
The highest rates of meningococcal disease occur early in the first year of
life, with most cases occurring within the first 7 months[2],[5]. About one in
16 infants who contract meningococcal disease may die[5]. Survivors may suffer
permanent brain damage, learning disabilities, hearing loss and limb loss[6]. In
most cases, the resulting side effects require life-long, expensive medical
treatment and ongoing assistance[7].
About Menveo
As of June 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. Menveo has been administered to more
than 21,500 participants in clinical trials across all age groups worldwide, and
studies are ongoing in infants, toddlers, adolescents and adults. Menveo
received FDA approval in February 2010 for use in adolescents and adults (11 to
55 years of age) and approval for use in children 2 to 10 years of age in
January 2011.
In the European Union, Menveo is indicated for use in persons 11 years and
above. Novartis 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 coming months. An application to support a label extension for use in
children 2 to 10 years of age has been submitted in Canada.
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 following administration of
Menveo.
Vaccinees 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 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, erthema,
irritability, induration, sleepiness, malaise, and headache. 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 "would," "plans," 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; 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, eye care,
cost-saving generic pharmaceuticals, consumer health products, preventive
vaccines and diagnostic tools. 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 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 Data on File.
2. Centers for Disease Control and Prevention. Vaccines and Preventable
Diseases. Factsheet: Meningococcal Diseases and Meningococcal Vaccines. August
2009. Available at:http://www.cdc.gov/vaccines/vpd-vac/mening/vac-mening-fs.htm.
Accessed on May 31, 2011.
3. Novartis. Menveo® Full Prescribing Information. January 2011.
4. Klein NP, Gill CJ, Bedell L, Karsten A, Dull PM. Pivotal safety and
immunogenicity of an investigational quadrivalent meningococcal vaccine
(MenACWY-CRM; Menveo®) in 4545 infants. Presented at the 48th Annual Meeting of
the Infectious Diseases Society of America in Vancouver, British Columbia,
Canada on October 21-24, 2010.
5. Cohn, A. et al. Changes in Neisseria meningitidis Disease Epidemiology in the
United States, 1998-2007: Implications for Prevention of Meningococcal Disease.
Clinical Infectious Diseases 2010:50.
6. Centers for Disease Control and Prevention. Epidemiology and Prevention of
Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 10th Edition,
2nd printing. April 2011 update. Available
at:http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm. Accessed on May
31, 2011.
7. Schaffner, W. et al. The changing epidemiology of meningococcal disease among
US children, adolescents, and young Adults. National Foundation for Infectious
Diseases. November 2004. Available
at:http://www.nfid.org/pdf/meningitis/FINALChanging_Epidemiology_of_Meningococca
l_Disease.pdf. Accessed on May 31, 2011.
# # #
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e-mail: investor.relations(at)novartis.com e-mail:
investor.relations(at)novartis.com
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Datum: 16.06.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 55601
Anzahl Zeichen: 13108
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