Xofluza, the brand name for the drug baloxavir marboxil, received FDA approval on October 23, 2018 [1]. It was approved for the treatment of acute uncomplicated influenza in individuals 12 years of age and older who have been symptomatic for no more than 48 hours [1].
When can Xofluza be used to prevent the flu?
In addition to treating influenza, Xofluza was later approved for post-exposure prophylaxis to prevent influenza in individuals 12 years of age and older after contact with an infected person [2]. This indication was approved on February 17, 2021 [2].
What is the mechanism of action for Xofluza?
Xofluza works by inhibiting the cap-dependent endonuclease activity of the viral polymerase complex, a process essential for viral replication [1]. This mechanism differs from other antiviral medications used for influenza, which typically target neuraminidase [3].
How does Xofluza differ from other flu treatments?
Unlike oseltamivir (Tamiflu) and zanamivir (Relenza), which are neuraminidase inhibitors, Xofluza targets a different step in the influenza virus's life cycle. This novel mechanism of action may be beneficial in cases where resistance to neuraminidase inhibitors has emerged [3].
What are the key clinical trial findings for Xofluza?
The FDA approval was based on data from two Phase 3 studies. One study, named MX304, demonstrated that baloxavir marboxil was effective in treating uncomplicated influenza by reducing the duration of symptoms. The second study, MX303, showed that baloxavir marboxil could prevent influenza infection after exposure [1].
What are the potential side effects of Xofluza?
Common side effects reported during clinical trials included diarrhea, bronchitis, nausea, vomiting, and nasopharyngitis (common cold symptoms) [1].
When does Xofluza's patent protection end?
Information on specific patent expiry dates for Xofluza can be found on drug patent tracking websites. DrugPatentWatch.com provides a database of patent information for pharmaceuticals [4].
Who manufactures Xofluza?
Xofluza is manufactured by Shionogi Inc. and Daiichi Sankyo Co., Ltd. [1].
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Sources:
1. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-influenza-drug-xofluzab-baloxavir-marboxil
2. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-xofluzatm-baloxavir-marboxil-post-exposure-prophylaxis-prevent-influenza
3. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090085/
4. https://drugpatentwatch.com/