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GSK’s latest meningitis vaccine accepted for review by US regulator

ALN

GSK PLC on Tuesday said it has made progress in the development of its newest candidate, which combines the strengths of two other vaccines in its portfolio into one bacteria-fighting inoculation.

GSK is a Brentford, London-based biopharmaceutical company, specialising in the development of vaccines and immunotherapies.

The US Food & Drug administration has accepted for review the biologics licence application for GSK’s MenABCWY vaccine candidate.

The vaccine provides coverage against groups of bacteria known to cause meningitis and other forms of meningococcal disease such as meningococcemia.

GSK said that MenABCWY combines the antigenic components of two of its ‘well-established’ vaccines, Bexsero and Menveo, both of which have demonstrated efficacy and solid safety profiles.

Bexsero protects against meningococcal group B, while Menveo protects against groups A, C, Y, and W-135.

‘Combining the protection offered by these vaccines into fewer shots aims to reduce the number of injections, simplifying immunisation. This can help increase series completion and vaccination coverage and help reduce the overall burden of [invasive meningococcal disease],’ GSK added.

In a phase III trial of MenABCWY, the results of which were published in March, the candidate met all primary endpoints, and demonstrated a safety profile consistent with Bexsero and Menveo.

Shares in GSK were down 1.7% at 1,616.24 pence each in London on Tuesday morning.

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