Following the recent news that Roche’s Phase III influenza drug Xofluza met its primary endpoint for influenza prevention, Philipp Rosenbaum, Pharma Analyst at GlobalData, a leading data and analytics company, offers his perspective:
“Given that seasonal influenza vaccines were only around 45% effective over the past 10 influenza seasons, a prophylactic label expansion for Xofluza could provide an important additional layer of protection against influenza infections, especially for high-risk groups like elderly patients or people with chronic diseases.
“Universal influenza vaccines that promise higher effectiveness and protection for multiple seasons are still several years away from market launch in the US, so antiviral drugs remain an important asset in fighting influenza virus infections. The seasonal influenza pipeline is highly active with more than 230 products in development, and Xofluza could help bridge the gap between vaccine effectiveness and the short time window for the benefit of antiviral treatment, which has to be administered within 48 hours of influenza infection.
“Additionally, this opens new commercial opportunities for Roche, whose blockbuster influenza drug Tamiflu patent expired three years ago and since lost most of its market share to generics. In the three years before Tamiflu generics hit the market, Tamiflu US sales were between $450 million and $750 million. Since its approval by the FDA in 2018, Xofluza has been off to a slow start in the US but has seen more promising numbers in Japan. Xofluza’s main advantage is it being a single-dose treatment instead of multiple doses over several days as for other currently available antivirals. A label expansion for influenza prevention could provide an additional competitive edge for Roche in the influenza antiviral market and bring back the sales numbers Roche lost to Tamiflu generics.”