Pfizer has won U.S. approval for its Trumenba vaccine against meningitis, a potentially deadly bacterial disease that has recently caused outbreaks on college campuses, the U.S. Food and Drug Administration said on Wednesday.
Trumenba, approved in individuals 10 to 25 years of age, has been considered one of the most important products in Pfizer's drug pipeline. It was granted accelerated approval following tests in 4,500 people in the United States, Europe and Australia.
It is the first approved U.S. vaccine that prevents invasive disease caused by the bacterium Neisseria meningitidis B, a strain that causes disease globally in an estimated 20,000 to 80,000 people a year, and accounts for an estimated 40 percent of meningitis infections in the United States, according to Pfizer.
Meningitis can be treated with antibiotics, but 10 to 15 percent of patients die and up to 19 percent of survivors have long term disabilities, including brain damage and limb amputations. Vaccination is deemed the best way to prevent the disease.
Pfizer and Swiss drugmaker Novartis had both won the FDA's coveted "breakthrough therapy" designation for their rival meningitis B vaccines and were racing for the first FDA approval.
© 2021 Thomson/Reuters. All rights reserved.