The European Commission (EC) has approved Roche’s oral treatment Xofluza (baloxavir marboxil) for the treatment of influenza.
The EC approval makes Xofluza the first new influenza antiviral available to patients in almost 20 years, Roche said in a statement.
The single-dose, oral medicine is now available in the EU as a treatment for uncomplicated influenza in patients aged 12 years and above, as well as for post-exposure prophylaxis of influenza in the same age groups.
“We are delighted that the European Commission has approved Xofluza, a first-in-class, single-dose oral medicine, for the treatment of influenza,” said Levi Garraway, chief medical officer and head of Global Product Development, Roche.
“Xofluza offers patients the first novel mechanism of action for treating influenza approved in Europe in almost 20 years. With approval for both treatment and post-exposure prophylaxis, we are hopeful Xofluza will help patients recover more quickly while also reducing the societal burden of influenza, especially amid the COVID-19 pandemic,” he aded.
In November 2020, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Xofluza in the subsequently approved indications.
The approval and CHMP recommendation are based on results from the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.
In the CAPSTONE-1 study, Xofluza significantly reduced the duration of flu symptoms by over one day compared with placebo, while in the CAPSTONE-2 study the oral flu treatment demonstrated a significant and clinically meaningful benefit in people at high-risk of complications from influenza.
In the BLOCKSTONE study, which evaluated Xofluza in the post-exposure prophylaxis setting, the treatment showed a statistically significant prophylactic effect on flu after a single oral dose, reducing the risk of individuals aged 12 years and above from developing flu after exposure to an infected household member by 90% compared to placebo.