Roche’s Xofluza (baloxavir marboxil) Receives EC’s Approval for the Treatment of Influenza in Children Aged ≥1 Year
Shots:
- Xofluza has been approved by the EC for use in children aged ≥1yr. for uncomplicated influenza & post-exposure prophylaxis of influenza
- The approval was based on the P-III study (miniSTONE-2) & (BLOCKSTONE) evaluating single-dose of Xofluza. The study (miniSTONE-2) met its 1EPs of safety & showed a reduction in the length of time that influenza was released from the body by ≥2 days vs oseltamivir (median time of 24.2 vs 75.8hrs.), was well tolerated with no new safety signals
- In the (BLOCKSTONE) study, significant prophylactic effects were observed after a single oral dose by lowering the risk of individuals after exposure to an infected household member (1.9% in Xofluza vs 13.6% in PBO). Xofluza has approved in 70+ countries for influenza types A & B
Ref: GlobeNewswire | Image: Roche
Related News:- Roche's Xofluza Receives the EC's Approval for the Treatment of Influenza
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