Xofluza, Fast-Acting Flu Drug from Japan, Shows Promise in Two NEJM Studies

But Could Lead to Viral Resistance

A new fast-acting flu drug, baloxavir marboxil (Xofluza, Shinogi), reduced the length of time that people were sick with flu symptoms by a little over a day, according to two recently published clinical trials that were reported in the New England Journal of Medicine (NEJM). The drug, the first in a new class of endonuclease inhibitors, also dramatically reduced the amount of viruses that people with infections had in their upper respiratory tracts, suggesting they might be less likely to infect others through coughs and sneezes.

Alas, the single-dose drug didn’t make people feel better faster than oseltamivir, sold as Tamiflu. And the studies showed viral resistance could develop rapidly to the drug — a finding described as concerning in an editorial the journal published along with the studies. Virus samples collected from nearly 10 percent of people treated in one of the trials showed mutations that are believed to allow the viruses to evade the effect of the drug.

Baloxavir is currently being given a priority review by the FDA, which promised in late June to rule within six months — which means a decision should be made before Christmas.

Source: Statnews.com, September 10, 2018