Australia approval marks a key step in expanding access to the first and only broad coverage vaccine against MenB disease[1],[2];Bexsero was granted European licensure this past January[1]
• MenB disease is a leading cause of meningitis and sepsis globally, and causes approximately 85 percent of all meningococcal disease cases in Australia[3],[4],[5]
• Bexsero safety and efficacy have been shown through clinical trials involving more than 8,000 people including infants, children, adolescents and adults[6]
Basel, August 15, 2013 – Novartis announced today that the Australian Therapeutic Goods Administration (TGA) has added Bexsero®, a multi-component Meningococcal B (MenB) vaccine (recombinant, adsorbed) suspension for injection 0.5 ml pre-filled syringe, to the Australian Register of Therapeutic Goods (ARTG) for use in individuals from two months of age and older[6]. Bexsero is the first and only broad coverage vaccine to help protect all age groups against MenB disease, including infants who are at the greatest…
View original post 7 more words
DRUG REGULATORY AFFAIRS INTERNATIONAL 