Pharmacy choice – pharmaceutical news – novartis bexsero vaccine approved by fda for the prevention of meningitis b, the leading cause of bacterial meningitis in the us – march 13, 2017

BASEL,Switzerland, Jan. Meningite symptome 23, 2015 /PRNewswire/ Novartis announced today that the US Food and Drug Administration (FDA) has granted accelerated approval of Bexsero (Meningococcal Group B Vaccine [recombinant, adsorbed]) for active immunization to prevent invasive meningococcal disease caused by serogroup B (also known as meningitis B) in adolescents and young adults from 10 years through 25 years of age. Cerebrospinal meningitis symptoms Bexsero is the only meningitis B vaccine approved in the US with a two-dose regimen and a flexible dosing schedule 1. Meningits As part of the accelerated approval process, Novartis will complete its ongoing studies to confirm the effectiveness of Bexsero against diverse serogroup B strains.

Experience the interactive multimedia release here:

“While rare, meningitis B is a devastating disease that can hit anyone anytime, especially teenagers and children,” saidAndrin Oswald, Division Head, Novartis Vaccines. Meningitis vaccine lump “This approval is an important milestone towards our goal of helping to prevent any further loss of life.”

In Phase II and Phase III studies, Bexsero demonstrated a protective immune response in adolescents and young adults after two doses. What causes meningitis in children Bexsero also offers a flexible dosing schedule, with the first and second doses administered at least one month apart 1.

“As someone who contracted meningitis during college, I am hopeful that young adults across the country will soon have routine access to meningitis B vaccines,” said Jamie Schanbaum, 25-year-old founder of the meningitis advocacy organization The J.A.M.I.E. I sintomi della meningite Group. Meningite bebe 1 mois “There is no reason that young people in the US should be in danger of a vaccine-preventable disease as devastating as meningitis.”

The tolerability profile of Bexsero was also demonstrated as part of a US Centers for Disease Control and Prevention (CDC)-sponsored clinical trial conducted in more than 15,000 individuals at Princeton University and the University of California, Santa Barbara (UCSB) during meningitis B outbreaks on these college campuses.

Meningitis viral treatment The safety data from the CDC clinical trial are consistent with results observed in previous studies 1,4.

Invasive meningococcal disease, which may present as bacterial meningitis, can be easily misdiagnosed and while rare, it can have serious consequences including lifelong disability and sometimes death within 24 hours of symptom onset 2,3. Viral meningitis child Neisseria meningitidis B has become the most prevalent of the serogroups that cause meningococcal disease in the US, accounting for 33 percent of all reported cases in 2013 5. Meningitis rash baby glass test Even with antibiotic treatment, as many as 10 percent of people infected with meningococcal disease will die and almost one in five survivors will suffer long-term disability 2. Meningitis recovery Adolescents and young adults are at an increased risk of contracting meningococcal disease due to common lifestyle habits, such as living in college dormitories 2.

In January 2013, Bexsero was approved by the European Commission for use in individuals from 2 months of age and older, making it the first broad coverage vaccine to receive a regulatory approval to help protect against meningitis B. Meningitis a c w y The US approval of Bexsero underscores the unique leadership position of Novartis in the global fight against meningococcal disease. Signs and symptoms of viral meningitis Together, Bexsero and Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine) help to protect against all five main serogroups of meningococcal bacteria (A, C, W-135, Y and now B) that cause the majority of cases in the US and around the world 1,3.

Bexsero is now licensed in 37 countries including the member states of the European Union, Australia and Canada for use in individuals from 2 months of age and older. Meningite gatto Since being first approved in Europe, over 1 million doses of the vaccine have been distributed outside the US. Meningitis b vaccine uk In the US, it is approved for use in adolescents and young adults from 10 years through 25 years of age 1. What is meningitis and how do you get it Last year, health officials in Canada released the initial results of a large-scale vaccination campaign with the Bexsero to help protect against meningococcal serogroup B within the Saguenay-Lac-Saint-Jean region of Quebec, Canada. Meningite herpetique symptomes The regional program is the first of its kind globally and has reached 81 percent of the campaign’s target population within the first three months. Meningitis disease symptoms This encompasses more than 45,000 infants, young children and adolescents from 2 months to 20 years of age. Meningite b toscana The interim safety surveillance report showed that Bexsero has been generally well tolerated, consistent with data found in clinical trials 6.

The foregoing release contains forward-looking statements that can be identified by words such as “may,” “will,” “goal,” “hopeful,” “soon,” “can,” or similar terms, or by express or implied discussions regarding potential additional marketing approvals for Bexsero and Menveo, or regarding potential future revenues from Bexsero and Menveo. Meningitis b outbreak You should not place undue reliance on these statements. Meningitis b vaccine in usa Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Meningitis vaccine for college students Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. Mild meningitis There can be no guarantee that either Bexsero or Menveo will be submitted or approved for any additional indications or labeling in any market, or at any particular time. Meningitis b rash Nor can there be any guarantee that Bexsero or Menveo will be commercially successful in the future. Adult meningitis In particular, management’s expectations regarding Bexsero and Menveo could be affected by, among other things, the uncertainties inherent in research and development, including unexpected clinical trial results and additional analysis of existing clinical data; unexpected regulatory actions or delays or government regulation generally; the company’s ability to obtain or maintain proprietary intellectual property protection; general economic and industry conditions; global trends toward health care cost containment, including ongoing pricing pressures; unexpected manufacturing issues, and other risks and factors referred to in Novartis AG’s current Form20-F on file with the US Securities and Exchange Commission. Meningitis while pregnant 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 provides innovative healthcare solutions that address the evolving needs of patients and societies. Meningitis usa Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. What bacteria causes bacterial meningitis Novartis is the only global company with leading positions in these areas. Meningitis symptoms rash In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Meningitis causes and symptoms Novartis Group companies employ approximately 133,000 full-time-equivalent associates and sell products in more than 150 countries around the world. Meningitis w vaccine For more information, please visit

Novartis is on Twitter. Meningitis in newborns Sign up to follow @Novartis at

2. Meningite neonatale Centers for Disease Control and Prevention (CDC). Meningitis survival rate Prevention and Control of Meningococcal Disease; Recommendations of the Advisory Committee on Immunization Practices (ACIP). Meningite hemorragica Morbidity and Mortality Weekly Report (MMWR). Enterovirus meningitis symptoms 2013; 62(2):1-13. What is fungal meningitis Available at: Meningitis refers to Accessed January 2015.

3. Meningitis b vaccine age Centers for Disease Control and Prevention (CDC). Infectious meningitis Signs & Symptoms – Meningococcal Meningitis, 2014. Meningitis b vaccine how many doses Available at: Signs of viral meningitis Accessed January 2015.

4. Meningitis on baby Patel M. Meningitis quizlet Outbreaks of Serogroup B Meningococcal Disease on University Campuses 2013. Symptoms of meningitis in babies Presented at: Advisory Committee on Immunization Practices (ACIP) meeting; February 26, 2014; Atlanta, GA. Meningitis symptoms 2 year old Available at: Meningitis empiric treatment Accessed January 2015.

5. Meningitis onset Centers for Disease Control and Prevention (CDC). What is meningitis disease Active Bacterial Core Surveillance (ABCs) Report Emerging Infections Program Network Neisseria meningitidis, 2013-provisional. Meningitis vaccine private Available at: Symptoms of pneumococcal meningitis Accessed January 2015.

6. Catching meningitis Agence de la sante et des services sociaux du Saguenay-Lac-Saint-Jean. How do you get meningitis “First wave of vaccination against meningococcal B (press release).” June 19, 2014. Meningite viral sequelas Available at: Meningitis hib Accessed January 2015.

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