Novartis, Pfizer seek
U.S. approval of meningitis vaccines
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[June 18, 2014]
By Ransdell Pierson
(Reuters) - Pfizer Inc and
rival Swiss drugmaker Novartis AG on Tuesday said they
had asked U.S. regulators to approve their vaccines to
prevent meningitis infections in people aged 10 to 25.
The companies are pushing for FDA approval of their respective
vaccines following recent widely publicized outbreaks of the
dangerous infectious disease at Princeton University and at the
University of California at Santa Barbara (UCSB).
Vaccines from both companies, which have been in development for
years, are designed to protect against the B strain of the
meningococcal bacterium, which causes about 40 percent of U.S.
meningitis infections each year and which current vaccines do not
protect against. Different vaccines are already available to protect
against other strains of the bacterium.
Novartis' new product against the B strain, called Bexsero, has been
approved in 34 countries, including the European Union and Canada,
since last year. And under a special designation from the FDA,
Novartis provided nearly 30,000 doses of Bexsero to students and
staff at Princeton and to UCSB in order to help control their
Pfizer's experimental product, named rLP2086, is being evaluated in
more than 20,000 participants. Analysts are expecting it to generate
annual sales of more than $500 million by 2020, if it is approved.
Both vaccines have been granted "breakthrough therapy" designations
from the U.S. Food and Drug Administration, meaning they are deemed
likely to show big improvement over existing products and deserve
more intensive FDA feedback on how to efficiently develop them.
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Meningitis is spread through coughing and exchanges of saliva, and
people living in dormitories or other crowded living quarters are
especially at risk.
Bacterial meningitis can cause the membranes covering the brain and
spinal cord to swell. The most severe cases can result in death,
hearing loss, brain damage, kidney disease or require the amputation
of limbs. Symptoms include fever, headaches and stiff neck.
(Reporting by Ransdell Pierson; Editing by Marguerita Choy)
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