- One-dose, oral Xofluza has been recommended for approval for the treatment of uncomplicated influenza in patients aged 12 years and above
- Xofluza has also been recommended for approval as a preventive treatment (post-exposure prophylaxis) of influenza in individuals aged 12 years and above
- If approved, Xofluza would be the first innovation in mode of action for an influenza antiviral approved by the
European Commission in almost 20 years
“Today’s CHMP recommendation brings patients with influenza one step closer to potentially benefiting from Xofluza’s oral one-dose regimen, setting adults and adolescents on the path to feeling better sooner compared to placebo,” said
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.4,5,6 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) in 1,436 individuals aged 12 and above in the US and
- Xofluza met its primary endpoint compared to placebo:
- Significantly reduced the duration of influenza symptoms by more than one day (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).
The most common adverse events reported were diarrhoea (3.0%), bronchitis (2.6%), nausea (1.3%) and sinusitis (1.1%), and all of these adverse events occurred at a lower frequency than placebo. 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 one-dose of Xofluza® (baloxavir marboxil) compared with placebo and oseltamivir in individuals aged 12 years and above
A total of 2,184 participants enrolled in the study and were randomly assigned to receive one, oral dose of 40mg or 80mg of Xofluza (according to body weight), placebo or 75mg of oseltamivir twice daily for five days. The predominant influenza virus in this study were the A/H3 subtype (46.9 to 48.8%) and influenza B subtype (38.3 to 43.5%). The most common risk factors were asthma or chronic lung disease (39.2%), age ≥65 years (27.4%), endocrine disorders (32.8%), metabolic disorders (13.5%), heart disease (12.7%), and morbid obesity (10.6%).
The primary objective of the study evaluated the efficacy of one-dose of Xofluza compared with placebo by measuring the 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).
About BLOCKSTONE3
BLOCKSTONE was a phase III, double-blind, multicentre, randomised, placebo-controlled, post-exposure prophylaxis study that evaluated one-dose of Xofluza® (baloxavir marboxil) compared with placebo in household members (adults and children)
Those 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 randomised to receive one-dose of Xofluza (dose according to body weight) or placebo as a preventive measure against developing influenza.
Xofluza showed a statistically significant prophylactic effect on influenza after one oral dose in people exposed to an infected household contact. The proportion of household members aged 12 years and above
About Xofluza® (baloxavir marboxil)
Xofluza is a first-in-class, one-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.11,12,13 Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.1,14
Xofluza is available in the US and in several other 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
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).1,2,3,15
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.4,5,6
About
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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]
[5]
https://www.who.int/news-room/fact-sheets/detail/influenza-(seasonal)
[6] Choi WS, et al. Severe influenza treatment guideline. Korean J Intern Med. 2014; 29.1.132-147.
[7]
[8] Klepser, M. Socioeconomic impact of seasonal (epidemic) influenza and the role of over-the-counter medicines. Drugs. 2014; 74, 13. 1467-1479.
[9] Low, D. Reducing antibiotic use in influenza: challenges and rewards. Clin Microbiol Infect. 14.4. 2008; 298-306.
[10] Stiver, G. The treatment of influenza with antiviral drugs. CMAJ. 2003;168(1):49–56.
[11]
[12] 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.
[13] 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.
[14] Noshi T, et al. S-033447/S-033188, a Novel Small Molecule Inhibitor of Cap-dependent Endonuclease of Influenza A and B Virus: In Vitro Antiviral Activity against Laboratory Strains of Influenza A and B Virus in Madin-Darby Canine Kidney Cells. Poster presentation at OPTIONS IX,
[15] Baker J, et al. Baloxavir Marboxil Single-dose Treatment in Influenza-infected Children. Pediatr Infect Dis J. 2020;39(8):700-705.
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