- The
European Commission (EC) has approved single-dose, oral Xofluza for the treatment of uncomplicated influenza in patients aged 12 years and above The EC has also approved Xofluza for post-exposure prophylaxis of influenza in individuals aged 12 years and above- Xofluza, with its rapid reduction in viral replication, could help patients recover more quickly, while also reducing the societal burden of influenza
“We are delighted that the
Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health.5,6 Globally, seasonal influenza epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.7,8,9 The WHO estimates that up to 72,000 people in the
About CAPSTONE-11
CAPSTONE-1 was a phase III multicentre, randomised, double-blind, placebo-controlled study that evaluated the efficacy and safety of Xofluza® (baloxavir marboxil) compared with placebo and oseltamivir in otherwise-healthy individuals with acute uncomplicated influenza, aged 12 and above in the US and
The primary endpoint of the study was time to alleviation of symptoms. Xofluza significantly reduced the duration of influenza symptoms by more than one day compared with placebo (median time 53.7 hours versus 80.2 hours; p<0.001). Similar efficacy results were seen between Xofluza and oseltamivir in relation to time to alleviation of symptoms (median time 53.5 hours versus 53.8 hours).
Xofluza was well tolerated in this study and no new safety signals were identified. The study was conducted in the US and
About CAPSTONE-22
CAPSTONE-2 was a phase III, multicentre, randomised, double-blind study that evaluated the efficacy and safety of single-dose of Xofluza® (baloxavir marboxil) compared with placebo and oseltamivir in individuals aged between 12 and 64 years, who were at high-risk of complications from influenza. The
The primary endpoint of the study was time to improvement of influenza symptoms. CAPSTONE-2 was the first prospective, controlled phase III clinical trial to demonstrate a significant and clinically meaningful benefit from an antiviral medicine in people at high-risk of serious influenza complications (median time to improvement in symptoms 73.2 hours for Xofluza, 102.3 hours for placebo, p<0.0001). Similar median time to improvement in symptoms was seen between the Xofluza and oseltamivir groups (73.2 hours vs 81.0 hours, respectively).
Xofluza was well tolerated in this study and no new safety signals were identified. The study was conducted globally by Shionogi & Co., Ltd.
About BLOCKSTONE3
BLOCKSTONE was a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated single-dose of Xofluza® (baloxavir marboxil) compared with placebo in household members (adults and children) who were living with someone with influenza confirmed by a rapid influenza diagnostic test (the ‘index patient’).
The primary endpoint of the study was the rate of laboratory-confirmed clinical influenza during the ten day period after receiving treatment. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose, by reducing the risk of individuals aged 12 years and above from developing influenza after exposure to an infected household member, by 90% versus placebo. The proportion of household members aged 12 years and above who developed laboratory-confirmed clinical influenza was 1.3% in participants treated with Xofluza and 13.2% in the placebo-treated group.
Xofluza was well tolerated in this study and no new safety signals were identified. The study was conducted in
About Xofluza® (baloxavir marboxil)
Xofluza is 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, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.16,17,18 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.1,19
Xofluza is available in more than 30 countries for the treatment of influenza types A and B. In the US, Xofluza is approved for the treatment of acute, uncomplicated influenza in patients aged 12 years and above 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 individuals 12 years of age and older. Xofluza was the first new antiviral to be approved by the FDA in 20 years, and is the first innovation in mechanism of action for an influenza antiviral approved by the EC in almost 20 years.4
Robust clinical evidence has demonstrated the benefit of Xofluza in several populations (otherwise-healthy, high-risk and post-exposure prophylaxis in individuals aged 12 years and above). Xofluza is being further studied in a phase III development programme, 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).1,2,3,20
Xofluza was discovered by Shionogi & Co., Ltd. and is being further developed and commercialised globally in collaboration with the
About
Influenza is one of the most common, yet serious, infectious diseases, representing a significant threat to public health. Globally, seasonal epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year.7,8,9
About
Founded in 1896,
The
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References
[1] Hayden F, et al. Baloxavir Marboxil for Uncomplicated Influenza in Adults and Adolescents. N Engl J Med 2018; 379:913-923.
[2] Ison M, et al. Early treatment with baloxavir marboxil in high-risk adolescent and adult outpatients with uncomplicated influenza (CAPSTONE-2): a randomised, placebo-controlled, phase 3 trial. Lancet Infect Dis. 2020;20(10):1204-1214.
[3] Ikematsu H, et al. Baloxavir Marboxil for Prophylaxis against Influenza in Household Contacts. N Engl J Med. 2020; 383.309-320.
[4] EMA. Tamiflu. [Internet; cited 2020 November]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/tamiflu
[5]
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[7]
[8]
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
[9] Choi WS, et al. Severe influenza treatment guideline. Korean J Intern Med. 2014; 29.1.132-147.
[10]
[11] Trigueiro-Loruro JM, et al. Virol. 2019;535:297-307.
[12] Mifsud, EJ, et al. Antiviral Res. 2019;169:104545.
[13] Hayden FG, & Pavia AT. Antiviral management of seasonal and pandemic influenza. J Infect Dis. 2006;194:S119–126.
[14] Uyeki TM, et al. Clinical practice guidelines by the
[15] Wallick C, et al. Presented at: IDWeek; 2018
[16]
[17] Noshi T, et al. In vitro Characterization of Baloxavir Acid, a First-in-Class Cap-dependent Endonuclease Inhibitor of the Influenza Virus Polymerase PA Subunit.
[18] Taniguchi K, et al. Inhibition of avian-origin influenza A (H7N9) virus by the novel cap-dependent endonuclease inhibitor baloxavir marboxil. Scientific Reports. 2019; 9:3466.
[19] Noshi T, et al. S-033447/S-033188, a Novel Small Molecule Inhibitor of Cap-dependent Endonuclease of Influenza A and B Virus.
[20] In Vitro Antiviral Activity against Laboratory Strains of Influenza A and B Virus in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX,
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