Regulatory Roche’s Xofluza approved by European Commission for children’s influenza...

Roche’s Xofluza approved by European Commission for children’s influenza treatment


The EC (European Commission) has approved Roche’s influenza treatment called Xofluxa, targeted toward children aged over a year. It can be used for post-exposure prophylaxis of the flu as well, which means people can use it to prevent catching the illness from an infected person. 

The decision made by the commission is based on the BLACKSTONE and phase III miniSTONE-2 studies.

Roche is a Swiss medicine manufacturer that was founded well over a century ago in 1896 in Basel, Switzerland. Since then it has grown and is now one of the largest biotech companies in the world and an in-vitro diagnostics leader. Roche has been focused on work in the treatment of influenza. 

The seasonal influenza epidemics cause over 3M cases of severe diseases in which millions need hospitalization and nearly 650,000 lose their lives annually. Before bringing Xofluza, Roche brought Tamiflu (oseltamivir) which made a significant difference as a treatment for influenza.

The company’s CMO (Chief Medical Officer), Levi Garraway (Ph.D., M.D) said, “We are delighted that the European Commission has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children. We are hopeful that Xofluza’s convenient single-dose oral regimen will help children recover quickly, as well as reduce the societal burden of influenza.”

In almost two decades, Xofluza is the only innovation in the mechanism of action (MOA) for a flu antiviral that is approved by the EC. Clinical evidence has shown Xofluza’s advantages in numerous populations. Shionogi & Co., Ltd. founded the drug and it is being developed further and being commercialized around the world in partnership with the Roche Group (including Genentech in the United States). 

According to the terms of the collaboration, the global rights to Xofluza are with Roche apart from Taiwan and Japan, which will remain with Shionogi & Co., Ltd. The drug is the only single-dose oral medication that has proved to be effective against numerous types of influenza that also include those that are resistant to oseltamivir.

Influenza is spreading in Europe and according to expectations it will affect 25% of children every year. Influenza transmission studies show that there is a 38% risk of contracting the disease from household members. 

Xofluza’s prophylactic treatment halts the duplication of the virus faster than oseltamivir and could reduce the spread of the flu. The primary endpoint of the miniSTONE-2 study was safety which it met and showed that in comparison to oseltamivir, it was much faster in removing the flu from the body (24.2 hours compared to 75.8 hours). The BLOCKSTONE study revealed that Xofluza reduced the risk of contracting the virus from a household carrier member by 86% compared to the placebo.

Over a year ago, the drug was approved for use in Europe for adolescents aged 12 or over as well as adults. Now it is approved in over seventy countries for types A and B of influenza. Phase III trials are ongoing for children aged 1 or below as well as to reduce the flu transmission to other family members in the household.

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