[{"orgOrder":0,"company":"Genentech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Genentech\u2019s New Drug Application for Xofluza for the Treatment of Influenza in Children","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Genentech","sponsor":"Shionogi","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genentech Announces FDA Approval of Xofluza for the Prevention of Influenza Following Contact With an Infected Person","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Genentech","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Genentech Announces FDA Approval of Xofluza to Treat Influenza in Children Aged Five and Older","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"F. Hoffmann-La Roche","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Roche Announces The European Commission Approval Of Xofluza For The Treatment And Prevention Of Influenza In Children Aged One Year And Above","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Shionogi","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiwan Approves Japan-Based Shionogi's Influenza Drug for Paediatric Use","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"April 2024","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Baloxavir Marboxil
Taiwan approved sNDA for Xofluza (baloxavir marboxil) for the treatment and postexposure prophylaxis for influenza virus infection for paediatrics aged 5 to <12 years.
Xofluza (baloxavir marboxil), a first-in-class, single-dose oral medicine with an innovative mechanism of action that has demonstrated efficacy in a wide range of influenza viruses.
Xofluza® (baloxavir marboxil) is first-in-class, single-dose oral medicine with an innovative proposed MOA that has demonstrated efficacy in influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains in non-clinical studies.
Xofluza is the first single-dose influenza medicine approved for post-exposure prophylaxis. The sNDA allows Xofluza® (baloxavir marboxil) to be used as a treatment to prevent influenza in people 12 years of age and older following contact with someone with influenza.
The filings are based on positive results from two Phase III studies, miniSTONE-2 and BLOCKSTONE, which were both recently presented as late breakers at the 2019 OPTIONS X congress in Singapore.