FDA approved Xofluza.
This is incredibly great news, because it is new the best medicine from influenza in the world.
Yesterday US Food and Drug Administration (FDA) has approved Xofluza™ (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.[1-2] Xofluza has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.
The FDA has granted priority consideration to the application for registration of Xofluza (Xeroxavir marboxil) from Shionogi, a Japanese company that treats flu. This means that it can be approved at the end of December of this year. In February of this year, the drug has already been approved in Japan.
The basis for granting the status were the positive results of clinical studies of the third phase. The effect of Xofluza is different from other anti-influenza drugs. It inhibits the keto-dependent endonuclease protein. The drug is intended for single use, whereas, for example, Tamiflu should be taken five days twice a day.
Baloxavir stops the spread of influenza virus in just 24 hours, while taking Tamiflu this period is 72 hours. It is also effective in some Tamiflu-resistant avian influenza strains.
- Shi F, et al. Viral RNA polymerase: a promising antiviral target for influenza A virus. Curr Med Chem. 2013;20(31):3923–34.
- Kawaguchi K, et al. Effects of S-033188, a cap-dependent endonuclease inhibitor, on influenza symptoms and viral titer: Results from a phase 2, randomized, double-blind, placebo-controlled study in otherwise healthy adults with seasonal influenza. Poster presented at ESWI 2017.
- Roche – Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza