Shionogi Announces Supplemental New Drug Application for XOFLUZA? in Japan for the Post-Exposure Prophylaxis of Influenza Virus Infection was Approved.
OSAKA, Japan, November, 27, 2020 ??Shionogi & Co., Ltd. (Head Office: Osaka, Japan; President and CEO: Isao Teshirogi, Ph.D.; hereafter "Shionogi") today announced that Shionogi received approval for the supplemental New Drug Application (sNDA) for XOFLUZA??for the post-exposure prophylaxis of influenza virus infection. The sNDA is based on data from the phase III BLOCKSTONE study.1, 2
Vaccination is widely available for the prevention of influenza virus infection, but since the type of influenza virus that prevails varies depending on the season, vaccination alone is not enough to completely control viral infections, onset, and exacerbation. Therefore, prophylactic administration of anti-influenza virus drugs has become an important option for preventing influenza in high-risk patients including chronic lung disease, metabolic disorders, age =65 years,3?within family with confirmed ifluenza. In particular, in hospitals and facilities for the elderly, in addition to robust vaccination and infection prevention measures, it is recommended by JAID to proactively administer anti-influenza virus drugs to healthy individuals exposed to someone with influenza from an early stage.4
We are aware of and understand the concerns about the influenza season coinciding with theCOVID-19 pandemic this year. In addition to infection prevention measures such as droplet infection precautions and hand hygiene, vaccination is strongly recommended for the prevention of influenza virus infections, and the importance of preventing influenza is increasing.5?With this approval, single-dose Xofluza??has become a new option for the prevention of influenza post-exposure, and is expected to contribute not only for the treatment of influenza (as per its existing approval) but also now for prevention upon exposure.
Shionogi is committed to ?Protect people worldwide from the threat of infectious diseases? as our key focus. We are not limiting ourselves to the research and development of therapeutic medications, but are also focused on the total care of infectious disease through awareness building, prevention and diagnosis and suppression of exacerbation. Shionogi will continue to work diligently to collect and analyze data on the efficacy and safety of Xofluza??and provide information for appropriate use.
?XOFLUZA?? Product Description
https://www.nejm.org/doi/full/10.1056/NEJMoa1915341
2.?????????Press release on October 16, 2019
Shionogi Filed for the Supplemental New Drug Application of XOFLUZA??in Japan for the Post-Exposure Prophylaxis of Influenza Virus Infection
3.?????????CDC Criteria
CDC website, People at High Risk For Flu Complications
4.???????? JAID statement 2012 ?Concept of Influenza Hospital Infection Countermeasures? (Including Facilities for the Elderly)
http://www.kansensho.or.jp/modules/guidelines/index.php?content_id=24
5.????? JAID statement ?Preparing for the simultaneous epiemics of influenza and COVID-19?
http://www.kansensho.or.jp/uploads/files/guidelines/2008_teigen_influenza_covid19.pdf
6.???????? T. Noshi et al. In vitro Characterization of Baloxavir Acid, a First-in-Class Cap-dependent Endonuclease Inhibitor of the Influenza Virus Polymerase PA Subunit. Antiviral Research 2018;160:109-117
7.???????? K. Taniguchi et al. Inhibition of avian-origin influenza A(H7N9) virus by the novel cap-dependent endonuclease inhibitor baloxavir marboxil. Scientific Reports volume 9, Article number: 3466 (2019)
8.?????????Press release on November 24, 2020
Shionogi Announces FDA Approval of XOFLUZA??(Baloxavir Marboxil) for the prevention of Influenza following contact with an infected person.
9.???????? Xofluza: Pending EC decision|European Medicines Agency
https://www.ema.europa.eu/en/medicines/human/summaries-opinion/xofluza
10.?????Press release on March 31, 2020
Shionogi Filed for the Supplemental New Drug Application of Xofluza??in Taiwan for the Post-Exposure Prophylaxis of Influenza Virus Infection