{"id":47210,"date":"2022-08-11T22:01:49","date_gmt":"2022-08-11T20:01:49","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/genentech-announces-fda-approval-of-xofluza-to-treat-influenza-in-children-aged-five-and-older\/"},"modified":"2022-08-11T22:01:49","modified_gmt":"2022-08-11T20:01:49","slug":"genentech-announces-fda-approval-of-xofluza-to-treat-influenza-in-children-aged-five-and-older","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/genentech-announces-fda-approval-of-xofluza-to-treat-influenza-in-children-aged-five-and-older\/","title":{"rendered":"Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older"},"content":{"rendered":"
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\n\u2013 Xofluza is the first and only single-dose oral medicine for the treatment of influenza to be approved for children as young as five years of age \u2013<\/i>\n<\/p>\n

\n\u2013 The FDA also approved Xofluza to prevent influenza in children aged five and older following contact with an infected person \u2013<\/i>\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza\u00ae<\/sup> (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. This marks the first single-dose oral influenza medicine approved for children in this age group. Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years of age following contact with someone with influenza.\n<\/p>\n

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\n\u201cDespite the ongoing COVID-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cXofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.\u201d\n<\/p>\n

\nAccording to the Centers for Disease Control and Prevention, influenza can be a serious illness for young children. During the ongoing COVID-19 pandemic, there have been significantly fewer influenza cases likely due in large part to social distancing and mask wearing. However, in the U.S. 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalizations and more than 100 deaths for children aged five to 17 caused by influenza.\n<\/p>\n

\n\u201cHistorically, school-aged children have played a significant role in the community transmission of influenza. The annual influenza vaccine continues to be the most important first step to prevent illness in children, though there can still be breakthrough cases where antiviral treatment is needed,\u201d said Dr. Pedro Piedra, miniSTONE-2 study investigator and professor of molecular virology and microbiology, pediatrics at Baylor College of Medicine. \u201cToday\u2019s FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza.”\n<\/p>\n

\nThe FDA approval is based on results from two Phase III studies, miniSTONE-2 and BLOCKSTONE. miniSTONE-2 evaluated Xofluza compared with oseltamivir in otherwise healthy children and included patients aged five to less than 12 years with an influenza infection and displaying influenza symptoms for no more than 48 hours. BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. The results from these studies were published in The <\/i>Pediatric Infectious Disease Journal <\/i>and The New England Journal of Medicine<\/i> respectively.\n<\/p>\n

\nAdverse events reported in at least 5% of pediatric patients (ages five to 11 years) treated with Xofluza included vomiting (5%) and diarrhea (5%).\n<\/p>\n

\nXofluza is already FDA-approved to treat influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications. Xofluza is also approved to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is available as a one-dose, single tablet.\n<\/p>\n

\nAbout Xofluza\u00ae<\/sup> (baloxavir marboxil)<\/b>\n<\/p>\n

\nXofluza is a first-in-class, single-dose oral medicine with an innovative proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies. Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.\n<\/p>\n

\nIn October 2018, Xofluza was first approved by the FDA for the treatment of acute, uncomplicated influenza in otherwise healthy people 12 years of age and older who have been symptomatic for no more than 48 hours, representing the first new antiviral to treat influenza in the U.S. in over 20 years.\n<\/p>\n

\nXofluza is being further studied in a Phase III development program, including children under the age of one (NCT03653364) as well as to assess the potential to reduce direct transmission of influenza from otherwise healthy patients to household contacts (NCT03969212).\n<\/p>\n

\nXofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialized globally in collaboration with the Roche Group (which includes Genentech in the U.S.) and Shionogi & Co., Ltd. Under the terms of this agreement, Roche holds worldwide rights to Xofluza excluding Japan and Taiwan, which will be retained exclusively by Shionogi & Co., Ltd.\n<\/p>\n

\nXofluza U.S. Indication<\/b>\n<\/p>\n

\nXOFLUZA is a prescription medicine used to:\n<\/p>\n