GlaxoSmithKline has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] for the development of the vaccine in the prevention of Invasive Meningococcal Disease (IMD) caused by serogroup B in children 2-10 years of age.
Bexsero is the first vaccine in the world to receive the Breakthrough Therapy Designation (BTD) twice. In 2014, Bexsero received BTD for development in the prevention of IMD in individuals 10-25 years of age and was subsequently granted Accelerated Approval in January 2015.
GSK Vaccines chief scientist Rino Rappuoli said: “This designation emphasises the importance of tackling big scientific challenges like meningitis B and breaking new ground in disease prevention through approaches like reverse vaccinology.
“GSK is committed to the pursuit of innovative vaccines that help protect against serious diseases with significant unmet need.”
Breakthrough Therapy Designation is designed to expedite the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and preliminary clinical evidence indicates that the drug or vaccine may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).1
Drugs and vaccines that receive Breakthrough Therapy Designation are eligible for all features of the FDA’s Fast Track designation, including more frequent communication with the FDA about the drug’s development plan and eligibility for Accelerated Approval and Priority Review, if relevant criteria are met.2
GSK Vaccines chief medical officer Dr Thomas Breuer said: “Thirty-five percent of all meningitis B cases in the US occur in children under 11 years old.3
“This designation is an important step forward in meningococcal prevention and extending the protection provided by this vaccine to a vulnerable age group in the US. We look forward to continuing to work with regulators and public health partners to make this vaccine available for them.”
Bexsero is licensed in more than 35 countries,6 including the U.S. In the U.S., Bexsero is approved for use in individuals from 10 years through 25 years of age.
The countries where Bexsero is licensed include the member states of the European Union and European Economic Area, Australia, Argentina, Chile and Uruguay, where Bexsero is approved for individuals two months of age and older, and in Canada for those aged 2 months to 17 years of age.
In Brazil, Bexsero is approved for use in individuals from two months to 50 years of age. To date, GSK has distributed more than 20 million doses of Bexsero worldwide.