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GSK’s Bexsero Dangles No More: Meningococcal B Vaccine Converts To Regular Approval

 
• By Sue Sutter

US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.

Legs dangling
There is one less "dangling" accelerated approval now that GSK's Bexsero has converted. • Source: Shutterstock

The US Food and Drug Administration’s biologics center has one less “dangling” accelerated approval on the books now that GSK plc’s meningococcal B vaccine Bexsero has converted to regular approval.

GSK’s supplemental biologics license application cleared the agency on 19 August, using data from the confirmatory trial to revise the current two-dose

Key Takeaways

  • GSK’s meningococcal B vaccine Bexsero has converted to regular approval more than 9 years after accelerated approval.

  • The confirmatory trial was delayed, and the study report milestone pushed back, with FDA agreement, GSK said

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