{"id":387075,"date":"2020-11-23T14:49:04","date_gmt":"2020-11-23T19:49:04","guid":{"rendered":"http:\/\/www.marketnewsdesk.com\/?p=387075"},"modified":"2020-11-23T14:49:04","modified_gmt":"2020-11-23T19:49:04","slug":"genentech-announces-fda-approval-of-xofluza-for-the-prevention-of-influenza-following-contact-with-an-infected-person","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/genentech-announces-fda-approval-of-xofluza-for-the-prevention-of-influenza-following-contact-with-an-infected-person\/","title":{"rendered":"Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person"},"content":{"rendered":"

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Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person<\/b><\/p>\n

\n\u2013 Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with an infected person (post-exposure prophylaxis) \u2013 <\/i><\/p>\n

\n\u2013 Genentech also provides an update on the sNDA filing for Xofluza in the pediatric setting <\/i>\u2013\n<\/p>\n

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE<\/a>)–
\nGenentech, 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) as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza (known as post-exposure prophylaxis). Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis.<\/p>\n

\n\u201cWith today\u2019s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,\u201d said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. \u201cWe\u2019re hopeful that reducing the burden of influenza may help to mitigate the strain on our healthcare system amid the COVID-19 pandemic.\u201d\n<\/p>\n

\nPost-exposure prophylaxis with single-dose Xofluza was evaluated in the Phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine<\/i>. BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members (adults and children) who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact. The proportion of household members 12 years of age and older who developed influenza was 1% in participants treated with Xofluza and 13% in the placebo-treated group. Xofluza was well tolerated in this study and no new safety signals were identified.\n<\/p>\n

\n\u201cThe flu is a serious illness that burdens households and sickens millions across the U.S. every year,\u201d said Serese Marotta, Chief Operating Officer at Families Fighting Flu. \u201cAs we are about to enter a flu season within a global COVID-19 pandemic, we welcome Xofluza as a single-dose flu medicine to be used preventively after exposure to flu.\u201d<\/b><\/p>\n

\nThe most frequently reported adverse events (occurring in at least 1% of adult and adolescent influenza patients treated with Xofluza) included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%).\n<\/p>\n

\nAdditionally, Genentech is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children (one to 12 years of age) and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.\n<\/p>\n

\nXofluza is already FDA-approved to treat acute uncomplicated 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. Although some of the symptoms of COVID-19 and influenza can look similar, the two illnesses are caused by completely different viruses. Xofluza is specifically designed to treat influenza viruses only and is not effective against SARS-CoV-2, the coronavirus causing COVID-19.\n<\/p>\n

About BLOCKSTONE <\/b><\/p>\n

\nBLOCKSTONE is a Phase III, double-blind, multicenter, randomized, placebo-controlled, post-exposure prophylaxis study that evaluated a single dose of Xofluza compared with placebo in household members (adults and children) who were living with someone with influenza confirmed by a rapid influenza diagnostic test (the \u2018index patient\u2019). The study was conducted by Shionogi & Co., Ltd. in Japan during the 2018-2019 influenza season.\n<\/p>\n

\nThose diagnosed with influenza were required to have onset of symptoms for less than 48 hours and participants were required to have lived with those diagnosed for more than 48 hours. The participants were randomized to receive a single dose of Xofluza (dose according to body weight) or placebo as a preventive measure against developing influenza.\n<\/p>\n

About Xofluza\u00ae<\/sup> (baloxavir marboxil)<\/b><\/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

\nXofluza is available in the U.S. and in several other countries for the treatment of influenza types A and B. In the U.S., Xofluza is approved for the treatment of acute, uncomplicated influenza in people 12 years of age and older who are otherwise healthy or at high risk of developing serious complications from influenza, and who have been symptomatic for no more than 48 hours. Xofluza is also approved for post-exposure prophylaxis of influenza in people 12 years of age and older following contact with an individual who has influenza. Xofluza was the first new antiviral to be approved by the FDA in 20 years.\n<\/p>\n

\nRobust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk and post-exposure prophylaxis). Xofluza 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 transmission of influenza from an infected person to healthy people (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

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

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