US-based drugmaker Pfizer has received accelerated approval from US Food and Drug Administration (FDA) for its Trumenba to treat Meningococcal B disease in adolescents and young adults.
As part of the breakthrough therapy designation and priority review programmes, FDA has reviewed and approved Trumenba.
The approval was granted to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged from ten to 25 years.
Pfizer vaccine research and development senior vice-president Dr Emilio Emini said: “The approval of Trumenba is an important public health advance in helping to protect adolescents and young adults from invasive meningococcal serogroup B disease, also known as meningitis B.
“Pfizer is proud to have developed the first and only FDA-approved vaccine that addresses an existing and urgent need in the efforts to help prevent this uncommon but life-threatening and devastating disease in the US.
“As a next step, we look forward to participating in discussions with the Centers for Disease Control and Prevention (CDC) regarding potential meningococcal group B vaccination recommendations.”
Trumenba includes two recombinant lipidated factor H binding protein (fHBP) variants from N. meningitidis serogroup B, one from fHBP subfamily A and another from subfamily B (A05 and B01).
According to the company, the approval was based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the US.
Efficacy of the drug against diverse serogroup B strains has not been confirmed, noted Pfizer.
The company will complete its ongoing studies to confirm the effectiveness of Trumenba against diverse serogroup B strains, under the accelerated approval process.