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Roche’s flu pill Xofluza moves closer towards EU approval

CHMP recommends drug for approval in the EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Roche’s flu pill Xofluza for approval, moving it closer towards regulatory authorisation within the EU.

The CHMP has recommended Xofluza (baloxavir marboxil) for approval in the EU as a treatment for uncomplicated influenza patients aged 12 years and above.

Separately, Xofluza has been recommended for approval in the EU for post-exposure prophylaxis of influenza in individuals aged 12 years and above.

Xofluza was originally discovered and developed by Japanese pharma company Shionogi, which retains the rights to Xofluza in Japan and Taiwan – 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.

The most recent CHMP recommendation 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.

Although a CHMP recommendation does not guarantee an approval, more often than not the EMA follows the Committee’s guidance.

According to the World Health Organization (WHO), approximately up to 72,000 people in the EU die prematurely due to causes associated with influenza each year.

“CHMP's recommendation brings patients with influenza one step closer to potentially benefiting from Xofluza’s oral one-dose regimen, setting adults and adolescents on the path to feeling better sooner compared to placebo,” said Levi Garraway, chief medical officer and head of global product development, Roche.

“We believe that access to effective antivirals for influenza, and particularly their use in the prophylactic setting, could help reduce the strain of the COVID-19 pandemic on healthcare systems in Europe,” he added.

Article by
Lucy Parsons

18th November 2020

From: Regulatory



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