Roche has announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza (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 in the US 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.
The company has also launched the Elecsys IGRA SARS-CoV-2 test in countries that accept the CE Mark. The Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection and vaccination. The company said the test will be an additional tool to make better-informed decisions around care, sanitary measures and treatment options. This will be particularly important for at-risk patient groups.
Xofluza and influenza
“Despite 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,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
“Xofluza 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.”
According to the U.S. 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 US 2018-2019 influenza season, there were more than 6 million illnesses, thousands of hospitalizations and more than 100 deaths among children aged five to 17 caused by influenza.
“Historically, 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,” said Pedro Piedra, miniSTONE-2 study investigator and Professor of Molecular Virology, Microbiology and Pediatrics at Baylor College of Medicine.
“Today’s FDA approval provides children with a single-dose antiviral option, Xofluza, to treat influenza.”
The FDA approval is based on results from two phase III studies: miniSTONE-2, which evaluated the use of Xofluza in children, and BLOCKSTONE, which evaluated Xofluza as a preventive treatment for household members, in both adults and children. The results from these studies were published in The Pediatric Infectious Disease Journal and The New England Journal of Medicine.
Xofluza 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.
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. Xofluza is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.
Xofluza is approved in more than 70 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 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 European Commission in almost 20 years.
Xofluza 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 US) 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.
Roche said the new Elecsys IGRA SARS-CoV-2 test supports the better understanding of immune response to SARS-CoV-2 infection and vaccination. The test will be an additional tool to make better-informed decisions around care, sanitary measures and treatment options. This will be particularly important for at-risk patient groups.
With the transition from a pandemic to an endemic state of COVID-19, there is an increasing need to better understand the adaptive response of the human immune system to SARS-CoV-2.
An effective antiviral immune response requires coordinated T- and B-cell activities. While B-cells produce antibodies that can potentially neutralize viruses, T-cells can target infected cells to prevent further viral replication and spread. SARS-CoV-2 infection, as well as COVID-19 vaccination, induce both T- and B-cell responses, in people with a normally functioning immune system, and a timely and well-coordinated T- and B-cell response is likely the key in infection control.
While antibody testing has been adopted to measure antibody-mediated immunity, there is increasing evidence that measuring the complementary T-cell response may play an important role in determining the overall protection level achieved.
The Elecsys IGRA SARS-CoV-2 test is intended as an aid in identifying individuals with an adaptive T-cell response to SARS-CoV-2, which is indicative of past exposure to the virus or COVID-19 vaccination.
“The Elecsys IGRA SARS-CoV-2 test can provide a deeper understanding into immune response,” said Thomas Schinecker, CEO of Roche Diagnostics.
“This in turn may help to understand and identify those at higher risk of progressing to severe disease during an existing or future infection. This is particularly important in immunocompromised and high-risk patient groups that represent up to 20% in a given population4. The test results can help healthcare professionals to provide them with long-term guidance like appropriate treatment.”
About the Elecsys IGRA SARS-CoV-2 test
The Elecsys IGRA SARS-CoV-2 test is intended as an aid in identifying individuals with an adaptive T-cell response to SARS-CoV-2, indicative of past exposure to the virus or COVID-19 vaccination. The Elecsys IGRA SARS‐CoV‐2 test combines in vitro T-cell stimulation, using SARS‐CoV‐2 antigens in the cobas IGRA SARS‐CoV‐2 Tubes developed in cooperation with LG Chem Life Sciences and an automated electrochemiluminescence immunoassay (ECLIA) for interferon gamma to qualitatively detect T cell-mediated immune response to SARS‐CoV‐2 in human whole blood.