FDA Accepts Novartis Vaccines & Diagnostics, Inc.'s sBLA to Expand Indication of Menveo(R) to Children 2-10 Years of Age
CAMBRIDGE, MA--(Marketwire - May 07, 2010) - Novartis Vaccines (NYSE: NVS)
- Menveo vaccine was licensed in February 2010 for use in people 11-55 years of age to help protect against four vaccine-preventable meningococcal serogroups(1)
- FDA also accepted separate sBLA including data which describes persistence of meningococcal antibodies in adolescents 22 months postvaccination
- Novartis plans to seek licensure of Menveo for infants in 2011
The US Food and Drug Administration (FDA) has accepted for review Novartis Vaccines' supplemental Biologics License Application (sBLA) which includes data to support use of Menveo® (Meningococcal [Groups A, C, Y and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) in children 2-10 years of age. The FDA also recently accepted for review a separate sBLA which includes data describing the persistence of meningococcal antibodies in adolescents 22 months postvaccination. Menveo is a quadrivalent meningococcal conjugate vaccine that was licensed by the FDA in February 2010 for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135 in individuals 11-55 years of age. Menveo does not prevent N. meningitidis serogroup B infections(1),(2).
The pediatric supplemental application is supported by Phase III trial data. The trial was stratified into two age subsets -- 2-5 years of age and 6-10 years of age. A total of 2,907 study participants were randomized to receive a single dose of Menveo (N=1278), a single dose of its comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine) (N=1270) or two doses of Menveo (N=359). The study measured, for each of the four serogroups, both the percentage of subjects who achieved an immune response as measured by seroresponse, and the proportion of subjects achieving human serum bactericidal antibody (hSBA) titers greater than or equal to 1:8. Additionally, the study examined functional antibody level as measured by geometric mean titers (GMT)(2).
The antibody persistence data were collected from a separate Phase III study in adolescents. This trial included a total of 597 participants who were randomized to receive either Menveo (N=278) or the comparator (the other currently US-licensed ACWY meningococcal conjugate vaccine) (N=191), or were enrolled as naïve controls (N=128). The primary objective was to assess the persistence of circulating meningococcal antibodies a median of 22 months postvaccination for meningococcal serogroups A, C, Y and W-135 using hSBA, expressed as the proportions of subjects with a titer greater than or equal to 1:8 and GMTs(3).
About meningococcal disease, a leading cause of bacterial meningitis
In the United States, the incidence of meningococcal disease is variable. Rates of the disease are unpredictable and vary greatly from year to year. Between 1975 and 2006, there were approximately 1,200 to 3,500 cases of meningococcal disease each year(4). Globally, there are more than 500,000 cases of meningococcal disease each year, leading to more than 50,000 deaths(5).
As many as 1 in 7 patients who contract meningococcal disease die from it(6). Approximately 1 in 5 meningococcal disease survivors suffers serious, permanent and devastating consequences, including limb amputations, seizures, paralysis, hearing loss and learning disabilities(4). Meningococcal disease is a leading cause of bacterial meningitis, which is an infection of the membrane around the brain and spinal cord, and sepsis, a life-threatening bloodstream infection(4),(7),(8). This disease progresses rapidly and, even with early and appropriate treatment, can lead to death within 24-48 hours of appearance of initial symptoms(9).
Five serogroups -- A, B, C, Y and W-135 -- cause the majority of meningococcal disease cases worldwide, and distribution of serogroups varies widely from geographic region to region and changes over time(8). Currently, in the United States, most disease is caused by serogroups B, C and Y(6). The prevalence of serogroup Y has increased over the last few years (from 9 percent of reported cases in 1990 to 1992 to 39 percent in 2006)(10),(11).
Since 2005, the Advisory Committee on Immunization Practices, a group of 15 experts who advise the US Centers for Disease Control and Prevention (CDC) on the control of vaccine-preventable diseases, has recommended routine immunization with a quadrivalent meningococcal conjugate vaccine for all adolescents, 11-18 years of age, college freshmen living in dormitories and people in other high risk groups who are 19 to 55 years of age(6),(12).
"Meningococcal disease is an important public health issue that is associated with significant morbidity and mortality, as well as economic and social costs to a community(4),(5),(6)," said Andrin Oswald, Division Head of Novartis Vaccines and Diagnostics. "The most effective way to combat this deadly disease is through vaccination(5)."
The Menveo development program continues in multiple Phase III clinical trials. Menveo has the potential to be utilized in a broad age range, and the company plans to seek supplementary licensures for use of the vaccine in other age groups. Novartis expects to file data to support an infant indication in 2011.
For more information, please visit www.menveo.com.
About Novartis Vaccines' global meningococcal franchise
Novartis Vaccines is a global leader in providing vaccines to protect against deadly meningococcal disease. Through industry-leading scientific expertise, the company is focused on extending critical meningococcal vaccines research. In addition to developing Menveo vaccine, Novartis Vaccines is developing a recombinant vaccine for its potential to provide broad coverage against multiple strains of serogroup B, for which no vaccine is currently available.
Menveo vaccine is based on the same proprietary technology Novartis Vaccines pioneered to produce Menjugate®, a meningococcal serogroup C conjugate vaccine approved in many countries outside the US since 2000. The company has already distributed more than 41 million doses of Menjugate around the world and produced MenZB®, a vaccine against a strain of meningococcus B specific to a recent outbreak in New Zealand.
Important Safety Information
Menveo is a vaccine indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menveo is approved for use in persons 11 to 55 years of age. Menveo does not prevent N. meningitidis serogroup B infections.
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 CRM197-, 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. 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 a 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 all subjects who received Menveo 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.
The foregoing release contains forward-looking statements that can be identified by terminology such as "plans," "potential," "expects," or similar expressions, or by express or implied discussions regarding potential new indications or labeling for Menveo, potential future approvals of additional Novartis vaccines, or the timing of any such approvals or regarding potential future revenues from such vaccines. 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 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. Nor can there be any guarantee that any additional vaccines will be approved for sale in any markets. Neither can there be any guarantee that any such approvals will be obtained at any particular time. Nor can there be any guarantee that Menveo or any additional vaccines will achieve any particular levels of revenue in the future. In particular, management's expectations regarding Menveo or any additional vaccines 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.
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 and molecular diagnostics 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 2009, the Group's continuing operations achieved net sales of USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D activities throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 100,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
1. U.S. Food and Drug Administration (FDA) Vaccines, Blood and Biologics. Menveo. Available at: http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm201342.htm. Accessed on April 14, 2010.
2. DRAFT Menveo® Highlights of Prescribing Information. March 2010.
3. Gil, C. et al. Antibody persistence 22 months after vaccination of adolescents with the Novartis investigational meningococcal ACWY-CRM197 conjugate vaccine or Menactra®. Presented at 14th International Congress on Infectious Diseases (ICID), March 9-12, 2010, Miami, FL.
4. Centers for Disease Control and Prevention. Epidemiology and Prevention of Vaccine-Preventable Diseases (The Pink Book: Course Textbook). 10th Edition, 2nd printing. February 2008 update. Available at: http://www.cdc.gov/vaccines/pubs/pinkbook/default.htm. Accessed on April 14, 2010.
5. World Health Organization. Meningococcal Position Paper. Weekly Epidemiological Record No. 44, 2002, 77, 329-340. Available at: http://www.who.int/immunization/wer7740meningococcal_Oct02_position_paper.pdf. Accessed on April 14, 2010.
6. Centers for Disease Control and Prevention. Prevention and Control of Meningococcal Disease - Recommendations of the Advisory Committee on Immunization Practices. MMWR 2005; 54 (RR07): 1-21. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5407a1.htm. Accessed on April 14, 2010.
7. Centers for Disease Control and Prevention. Meningitis: Questions & Answers. June 2009 update. Available at: http://www.cdc.gov/meningitis/about/faq.html. Accessed on April 14, 2010.
8. 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_Meningococcal_Disease.pdf. Accessed on April 14, 2010.
9. World Health Organization. Meningococcal Meningitis fact sheet. Available at: http://www.who.int/mediacentre/factsheets/fs141/en/. Accessed on April 14, 2010.
10. Centers for Disease Control and Prevention. Active Bacterial Core Surveillance (ABCs) Report, Emerging Infections Program Network, Neisseria meningitidis, 1997-2006. Available at: http://www.cdc.gov/abcs/reports-findings/surv-reports.html. Accessed on April 14, 2010.
11. Nelson KE ea, eds. Infectious Disease Epidemiology: Theory and Practice. 2nd ed. Sudbury, MA: Jones & Bartlett Publishers; 2007.
12. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices. Recommended Immunization Schedule for Persons Aged 7 Through 18 Years -- United States, 2010.