The US Food and Drug Administration on Wednesday approved the first generic version of Roche's Xofluza, a single-dose influenza treatment for patients aged five years and older. The decision allows rival drugmakers to market lower-cost alternatives to the antiviral, which generated CHF 6 million in sales during the first nine months of 2022.
The US Food and Drug Administration approved the first generic version of Roche's Xofluza on Wednesday, opening the flu market to lower-cost competition.
The approval covers patients aged five years and older with uncomplicated influenza, the regulator said. Xofluza (baloxavir marboxil) requires a single dose, compared with Tamiflu's 10-day course for post-exposure prophylaxis.
Xofluza generated CHF 6 million ($6.4 million) in sales in the first nine months of 2022, a fraction of the blockbuster revenue Tamiflu once delivered for Roche. The drug was approved in the US last August for treatment in children aged five years and older and for post-exposure prophylaxis in those aged over 12.
The generic approval threatens to erode Roche's pricing power for Xofluza just as the drug was gaining regulatory momentum. The company had expanded Xofluza's European label earlier this year to include children as young as one year, positioning it as a potential successor to Tamiflu, which lost patent protection years ago.
Xofluza became the first influenza antiviral with a new mechanism of action in almost 20 years when it launched, according to Roche. The single-dose regimen offers a convenience advantage over Tamiflu, which requires once-daily dosing for 10 days in the prevention setting.
The current flu season has been particularly aggressive, with Belgium and Germany declaring epidemics and the UK's NHS reporting rising hospitalizations. Children and young adults have been most affected, according to Sciensano virologist Steven Van Gucht.
The generic approval means Roche's window to capture significant Xofluza revenue before facing competition has narrowed. Investors will watch for updated Xofluza sales figures in Roche's next quarterly earnings report for signs of erosion.
This article is for informational purposes only and does not constitute investment advice.
