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Roche’s flu pill Xofluza gains EU approval

EU approval is based on results from three phase 3 studies

Swiss pharma company Roche has scored approval from the European Commission (EC) for its flu pill Xofluza.

The EC has authorised Xofluza (baloxavir marboxil) for the treatment of uncomplicated influenza in patients aged 12 years and above.

Separately, the EC has also approved the oral treatment for post-exposure prophylaxis of influenza in individuals aged 12 years and above.

The EC authorisation comes less than two months after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended Xofluza for use in both indications.

“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, Roche’s chief medical officer and head of Global Product Development.

“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 added.

The EU approval is based on results from three phase 3 studies: CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE.

In the CAPSTONE-1 study, Xofluza significantly reduced the duration of influenza symptoms by more than one day, while the CAPSTONE-2 trial demonstrated a significant and clinically meaningful benefit associated with Xofluza treatment in high-risk influenza patients compared to placebo.

The BLOCKSTONE trial, which evaluated one dose of Xofluza compared with placebo in household members who were living with someone who had had a diagnostic test confirming a case of influenza, found that the drug had a statistically significant prophylactic effect on influenza occurrences.

The proportion of household members aged 12 years and above who developed influenza was 1.3% in the Xofluza treatment group compared to 13.2% in the placebo arm.

Xofluza was originally discovered and developed by Japanese pharma company Shionogi, which retains the rights to Xofluza in Japan and Taiwan, while Roche holds the remaining worldwide rights to the drug.

This includes the rights to the drug in the US, where the drug is approved for acute uncomplicated influenza in patients aged 12 years and above. It is also approved in the US for the treatment of people who have a high risk of developing influenza-related complications.

This includes influenza patients who have conditions including asthma, chronic lung disease, diabetes, heart disease or morbid obesity or adults aged 65 and over.

Article by
Lucy Parsons

11th January 2021

From: Regulatory



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