GSK’s meningitis B vaccine Bexsero receives Breakthrough Therapy Designation from U.S. FDA for prevention of invasive meningococcal disease 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 invasive meningococcal disease (IMD) in individuals 10-25 years of age and was subsequently granted accelerated approval in January 2015.
“This designation emphasizes the importance of tackling big scientific challenges like meningitis B and breaking new ground in disease prevention through approaches like reverse vaccinology,” said GSK Vaccines chief scientist Rino Rappuoli, who spent more than 20 years developing Bexsero, said.
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
“Thirty-five percent of all meningitis B cases in the U.S. occur in children under 11 years old,”3 Dr. Thomas Breuer, GSK Vaccines chief medical officer said. “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.
1 U.S. Food and Drug Administration. Breakthrough Therapy https://www.fda.gov/forpatients/approvals/fast/ucm405397.htm
2 U.S. Food and Drug Administration. Fast Track https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm
3 CDC Enhanced Meningococcal Disease Surveillance Report (2016) https://www.cdc.gov/meningococcal/downloads/NCIRD-EMS-Report.pdf
(Source: GlaxoSmithKline plc)
Filed Under: Drug Discovery