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Roche: FDA Approves Influenza Drug Xofluza For Post-exposure Prophylaxis

Swiss drug maker Roche Group (RHHBY) announced Tuesday that the U.S. Food and Drug Administration has approved a supplemental New Drug Application or sNDA for Xofluza (baloxavir marboxil) for the prevention of influenza in people 12 years of age and older following contact with an infected person, known as post-exposure prophylaxis.

Xofluza is the first single-dose influenza medicine approved to prevent influenza for those who have had contact with someone with influenza.

Although some of the symptoms of COVID-19 and influenza can look similar, the two illnesses are caused by completely different viruses. Xofluza is specifically designed to treat influenza viruses only and is not effective against SARS-CoV-2, the coronavirus causing COVID-19.

The company noted that post-exposure prophylaxis with single-dose Xofluza was evaluated in the phase III BLOCKSTONE study, which was recently published in The New England Journal of Medicine.

BLOCKSTONE evaluated Xofluza compared with placebo as a preventive treatment for household members, i.e., adults and children, who were living with someone with influenza. Xofluza showed a statistically significant prophylactic effect on influenza after a single oral dose in people exposed to an infected household contact.

Xofluza was well tolerated in this study and no new safety signals were identified.

Roche also provided an update on the sNDA filing for Xofluza in the pediatric setting. The company said it is determining a path forward with the FDA for a potential indication for Xofluza as a treatment for acute uncomplicated influenza in otherwise healthy children - one to 12 years of age and for the prevention of influenza in the same age group who have been exposed to influenza. Xofluza is currently not approved for use in this population.

Xofluza is already FDA-approved to treat acute uncomplicated influenza in people 12 years of age and older who have had influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

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