US FDA approves new format of GSK's Shingrix

(Sharecast News) - GSK announced on Thursday that it has received approval from the US Food and Drug Administration for a new prefilled syringe presentation of its shingles vaccine, Shingrix. The FTSE 100 company said the change eliminated the need for reconstitution prior to administration, streamlining the process for healthcare providers.

It said the current format of Shingrix required healthcare professionals to combine a lyophilised antigen with a liquid adjuvant before injection.

The newly-approved version simplifies that by offering a ready-to-use format, following data demonstrating technical comparability with the original presentation.

GSK said the prefilled syringe would be available under the same indications as the original version.

It is approved in the US for adults aged 50 and over, and for those aged 18 and over who are immunocompromised due to disease or therapy.

The CDC recommends a two-dose regimen of Shingrix in these populations.

"At GSK, we are committed to advancing scientific innovation and delivering practical solutions that address the needs of the healthcare community," said Tony Wood, chief scientific officer at GSK.

"This new presentation of Shingrix was developed to streamline the vaccination process, supporting healthcare professionals to provide protection against shingles, a disease that one in three US adults will develop in their lifetime."

The new presentation was also under review by the European Medicines Agency, with filing accepted in January.

GSK said it was considering submissions in additional markets as part of its wider push to expand adult immunisation.

It said shingles affects around one million Americans annually and is caused by the reactivation of the varicella-zoster virus.

While not all who carry the virus will develop shingles, risk increases with age as immune function declines.

At 0902 BST, shares in GSK were down 0.46% at 1,415p.

Reporting by Josh White for Sharecast.com.