Novartis, Pfizer seek U.S. approval of meningitis vaccines

Novartis office

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 outbreaks.
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.
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.