Roche Reports Positive Results of Xofluza (baloxavir marboxil) in Two P-III MINISTONE-2 and BLOCKSTONE Studies for Influenza Infection

Shots:

• The P-III MINISTONE-2 involves assessing of Xofluza vs oseltamivir in children with influenza infection & showing influenza symptoms aged 1 to <12yrs., resulted in meeting its 1EPs i.e, patients with AEs up to day 29 (46.1% vs 53.4%) and reduction in length of time that the flu virus continued to be released from the body by >2days (24.2 vs 75.8 hrs.)
• The P-III BLOCKSTONE study involves assessing of Xofluza vs PBO in adults & children with influenza infection confirmed by a rapid influenza diagnostic test. The results demonstrated 86% reduction in developing flu after exposure to an infected person (1.9% vs 13.6%), when fewer criteria for flu were applied showed 76% reduction in developing flu (5.3% vs 22.4%)
• Xofluza is a one-dose, oral therapy demonstrating efficacy in a wide range of influenza viruses including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies and is an approved therapy in the US for acute influenza in patients aged ≥12yrs.

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