USFDA Issues Second Breakthrough Therapy Title for GSK’s Vaccine
GlaxoSmithKline’s meningitis B vaccine Bexsero [Meningococcal group B Vaccine (rDNA, component, adsorbed)] has now received a Breakthrough tag for the prevention of invasive meningococcal disease in children ages 2 -10.
It is currently approved in the U.S. for people aged 10 – 25 for which it had received BTD for development in the prevention of IMD in 2015. Bexsero is the first vaccine in the world to receive the Breakthrough Therapy Designation (BTD) twice.
Invasive meningococcal B disease is the leading cause of life-threatening meningitis in the industrialized world. The disease can develop rapidly in healthy populations and can result in high morbidity and mortality.
The designation will 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).
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.
GSK
Vaccines Chief Scientist Rino Rappuoli, who spent more than 20 years developing Bexsero, 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.”“Thirty-five percent of all meningitis B cases in the U.S. occur in children under 11 years old. 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 U.S. We look forward to continuing to work with regulators and public health partners to make this vaccine available for them,” Thomas Breuer, GSK Vaccines chief medical officer said.
