Genentech, Biotechnology Company announced that it received FDA grant for priority review of baloxavir marboxil and would decide whether to approve it by the end of 2018
The U.S. Food and Drug Administration (FDA) granted priority review to a new antiviral drug that reported to lower influenza symptoms. This single-dose drug is fast-acting and will potentially be approved for use in the U.S. by the end of 2018. Baloxavir marboxil has novel mechanism of action, unlike any other previously produced anti-influenza medication. Inside the human body the drug metabolizes into baloxavir acid, a compound that inhibits a key enzyme called influenza polymerase. Without this enzyme the influenza virus is unable to replicate.
The results from the human trial into the drug’s efficacy suggested that it could be an incredibly useful new tool in a doctor’s arsenal. In comparison to placebo, the drug reduced the duration of flu symptoms by over a day and reduced the duration of fever to just 24 hours. As well as shortening the overall duration of the infection, an even more impressive effect of the drug was its ability to reduce the time a person is infectious to others. The trial indicated that the drug lowers the duration of what is referred to as ‘viral shedding’ from an average of 96 hours to just 24 hours.
The drug has already been approved for use in Japan and is being marketed in that country under the brand name Xofluza. However, cost of the drug is not disclosed yet in the U.S. In Japan a dose is priced at US$ 43.50, a reasonable price for a one-and-done medication. The drug is only approved for use in persons over the age of 12. Pediatric trials are currently underway to establish safety and efficacy in younger patients.