Trumenba has been approved by the Food and Drug Administration (FDA) in the battle against meningitis. The disease frequently breaks out on college campuses, and is a major health concern nationwide, claiming lives of young adults.
The vaccine is approved for use in patients from ages 10 to 25, and would be provided by a series of three injections, with the second and third delivered two and six months after the first.
Tests of the drug examined 4,500 subjects in the United States, Australia, and Europe.
Neisseria meningitis B infects between 20,000 and 80,000 people each year worldwide, and is responsible for 40 percent of all meningitis cases diagnosed in the United States. Trumenba is the first vaccine approved in the United States to prevent infections from this form of the bacteria.
"Recent outbreaks of serogroup B Meningococcal disease on a few college campuses have heightened concerns for this potentially deadly disease. The FDA's approval of Trumenba provides a safe and effective way to help prevent this disease in the United States," Karen Midthun, director of the Center for Biologics Evaluation and Research at the Food and Drug Administration, said.
Meningitis can usually be treated using antibiotics. However, more extreme cases can take the lives of between 10 and 15 percent of patients. Roughly 19 percent of those who survive the illness suffer from debilitating conditions, including brain damage. Limb amputations are also common among those who suffer from extreme cases of meningitis, along with learning disabilities and hearing loss. Most health care professionals believe vaccines remain the best option for fighting infections.
"Meningococcal disease can progress from initial symptoms to death within 24 hours, and is often challenging to diagnose and distinguish from diseases that are more common and less serious, making preventative vaccination critically important," Stanley Block, MD, a physician at Kentucky Pediatric/Adult Research, said.
A total of 2,800 adolescents were treated with three doses of Trumenba, and 82 percent of the subjects developed antibodies capable of destroying four different forms of N. meningitis serogroup B. These results were cited by the FDA as evidence supporting accelerated approval of the drug.
Novartis, a rival pharmaceutical company from Switzerland has also developed a vaccine to treat meningitis B. The FDA declared vaccines from each company were "breakthrough therapies," and developers raced to be the first to win federal approval.
Trumenba was considered, by many industry observers, to be one of the drugs under development offering the greatest potential profits for pharmaceutical giant Pfizer.
"The most commonly reported side effects by those who received Trumenba were pain and swelling at the injection site, headache, diarrhea, muscle pain, joint pain, fatigue and chills," the Food and Drug Administration reported.
