Roche’s influenza medicine approved by EC for children
Roche’s Xofluza (baloxavir marboxil) has been approved by the European Commission (EC) to treat and prevent uncomplicated influenza in children aged one year and over.
With the EC’s decision, Xofluza is now the first single-dose, oral influenza medicine approved in Europe for children.
The approval was based on phase 3 trial results taken from miniSTONE-2, which assessed the use of Xofluza in children, and BLOCKSTONE, which assessed Xofluza in both adults and children as a preventive treatment for households.
The miniSTONE-2 study met its primary endpoint of safety and demonstrated that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir.
Time to alleviation of influenza signs and symptoms were comparable between Xofluza and oseltamivir, Roche reported, at 138 hours and 150 hours, respectively.
In the BLOCKSTONE study, Xofluza demonstrated a statistically significant prophylactic effect after a single oral dose, by reducing the risk of developing influenza after exposure to an infected household member by 86% versus placebo.
Commenting on the decision, Levi Garraway, Roche’s chief medical officer and head of global product development, said: “We are delighted that the EC has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children.
Read more: https://www.pmlive.com/pharma_news/roches_influenza_medicine_approved_by_ec_for_children_1485236
With the EC’s decision, Xofluza is now the first single-dose, oral influenza medicine approved in Europe for children.
The approval was based on phase 3 trial results taken from miniSTONE-2, which assessed the use of Xofluza in children, and BLOCKSTONE, which assessed Xofluza in both adults and children as a preventive treatment for households.
The miniSTONE-2 study met its primary endpoint of safety and demonstrated that Xofluza reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir.
Time to alleviation of influenza signs and symptoms were comparable between Xofluza and oseltamivir, Roche reported, at 138 hours and 150 hours, respectively.
In the BLOCKSTONE study, Xofluza demonstrated a statistically significant prophylactic effect after a single oral dose, by reducing the risk of developing influenza after exposure to an infected household member by 86% versus placebo.
Commenting on the decision, Levi Garraway, Roche’s chief medical officer and head of global product development, said: “We are delighted that the EC has approved Xofluza for children aged one year and above, as influenza can be particularly dangerous for younger children.
Read more: https://www.pmlive.com/pharma_news/roches_influenza_medicine_approved_by_ec_for_children_1485236
