FDA approves Xofluza for high-risk flu patients

October 22, 2019

It’s the first antiviral medicine specifically approved for patients with a high risk of developing serious complications from influenza.

A flu medicine specifically for patients at a high risk of serious complications from the disease had a supplemental new drug application accepted by the FDA on October 17.

Xofluza (baloxavir marboxil) was approved for acute, uncomplicated influenza in people 12 and over who have been symptomatic for 48 hours or less who are at high risk of developing flu-related complications. It is a one-dose oral medicine with a mechanism of action the inhibits polymerase acidic endonuclease, which is an enzyme essential to viral replication, according to a news release from Genentech.

“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” says Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease.”

The drug was previously approved by the FDA in October 2018 for the treatment of acute, uncomplicated flu in otherwise healthy people over the age of twelve who have been symptomatic for less than 48 hours, becoming the first new antiviral medicine to treat the disease in the United States in 20 years.

In a CAPSTONE-2 study which compared Xofluza with placebo and oseltamivir, researchers found:

·      The drug significantly reduced the time to improvement of flu symptoms with a median time of 73 hours versus 102 hours with placebo and 81 hours with oseltamivir

·      In subjects infected with type B flu virus, the median time of recovery in those taking Xofluza was shorter than the placebo group, with 75 hours to the placebo’s 101 hours

·      There were adverse side events reported in at least one percent of adult and adolescent patients who took Xofluza which included diarrhea, bronchitis, nausea, sinusitis, and headache

Xofluza is currently undergoing further testing on children under the age of one, the severely ill, hospitalized people with the flu, and also to assess the potential to reduce transmission of the flu from an infected person to healthy people.

Currently, it is unknown if the drug is safe and effective in children younger than 12 or weighing less than 88 pounds, the release says.