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GSK shingles treatment application accepted for review in Europe

ALN

GSK PLC on Monday said the European Medicines Agency accepted for review its application for an alternative treatment for shingles.

The Brentford, England-based pharmaceutical and biotechnology firm said the application was for a prefilled syringe presentation of Shingrix, GSK’s recombination zoster vaccine for the prevention of shingles, or herpes zoster.

Shingles usually presents as a rash, with painful blisters across the chest, abdomen or face, and 30% of people experiencing PHN, a nerve pain that can last weeks, months or even years. The condition is associated with ‘significant healthcare and human cost’.

The new prefilled syringe removes the need for filling up separate vials before administering treatment, offering a more convenient option for healthcare professionals, GSK said.

The vaccine has the same composition as the reconstituted vaccine, and the submission is based on data comparing the two treatment options.

This European review of the prefilled syringe follows GSK’s receipt of approval from the US Food & Drug Administration on January 8.

GSK is also investigating submission of the new presentation to ‘other markets’.

Shares in GSK were up 1.5% at 1,377.71 pence each in London on Monday morning.

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