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Roche: Xofluza approval expanded in US

(CercleFinance.com) - Roche announced that the FDA has approved a supplemental application for Xofluza for the treatment of acute uncomplicated influenza in healthy children aged 5 to 12 years who have been asymptomatic for over 48 hours.


It is the first single-dose oral influenza drug approved in the US for this age group. In addition, the FDA has approved Xofluza for prevention in children aged five to 12 years after contact with someone who has influenza.

This FDA approval is based on the results of two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine, respectively.

During the 2018-19 flu season in the US, there were over six million illnesses, thousands of hospitalisations and more than 100 deaths in children aged five to 17 years caused by influenza, the Swiss health group points out.



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