Roche tacks on another Xofluza indication as flu season meets pandemic
Xofluza was heralded as the first new flu drug in 20 years when it got the FDA OK back in 2018. But even so, Roche saw tough competition from cheaper Tamiflu generics that appeared to be nearly as — if not just as — effective.
Now, the pharma says the drug also can be used to prevent influenza after exposure, snagging a new approval and adding to Xofluza’s appeal as flu season meets the pandemic.
“With today’s approval, Xofluza is now available as the first single-dose, post-exposure preventive treatment for influenza,” Genentech CMO and head of global product development Levi Garraway said in a statement.
In the Phase III BLOCKSTONE study conducted in Japan, Xofluza was evaluated against a placebo as a preventative treatment for adults and children over 12 who were living in the same household as someone with the flu. Participants were required to have lived with that flu-infected household member for more than 48 hours before receiving either the treatment or placebo. And those with the flu had to have an onset of symptoms of less than 48 hours. Results showed that 1% of those in the treatment arm ended up contracting the flu, compared to 13% in the placebo group, Roche said.
The most common side effects included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%) and headache (1%).
Roche licensed Xofluza from Shionogi, which holds the rights in Japan and Taiwan. Its 2018 approval was much-needed for Roche, whose Tamiflu was battered by cheaper generics. Like Tamiflu, Xofluza reduced flu symptoms, but did not cure the illness. The company touted single-dose Xofluza’s convenience compared to Tamiflu, which requires 10 doses over 5 days. But with similar efficacy data, some consumers opted for the cheaper price tag on Tamiflu generics.
And last year, a study in Nature confirmed that Xofluza was linked to specific mutations with reduced susceptibility. “In a worst case scenario, these mutations could render the drug entirely useless,” Andrew Pekosz, a molecular biologist at Johns Hopkins who was not involved in the study, told Endpoints News last November. “They haven’t yet, and it’s not clear why that’s been the case.”
Last October, Roche expanded Xofluza’s label to include those at high risk of developing flu-related complications. It’s also approved in the US and abroad for the treatment of influenza types A and B, and in the US for acute, uncomplicated influenza in those 12 and older.
Next up, Roche is seeking potential approval for acute uncomplicated influenza in children from 1 to 12 years old, and for prevention for patients in the same age group who have been exposed to influenza.