ゾフルーザのFDA認可は高リスク者限定

米FDAのゾフルーザ認可。日本の騒動を眺めてか、高リスク群限定の認可です。

• Genentech社（ロシュ）、New Drug Application (sNDA) for Xofluza^™ (baloxavir marboxil) 。FDA認可。対象は、合併症の高リスク群。
• 糖尿病、慢性肺疾患、喘息、肥満、65歳以上。

 

https://www.cathlabdigest.com/content/genentech-announces-fda-approval-xofluza-baloxavir-marboxil-people-high-risk-developing-influenza-related-complications?fbclid=IwAR3qIgqkfiVbPD7JjTCpBvwSv0CQjj2CwAG199xEU-pDEQWoTbRzuNcUCXw

Genentech Announces FDA Approval of Xofluza (Baloxavir Marboxil) for People at High Risk of Developing Influenza-Related Complications

 

元ソースにゾフルーザの要点。

Xofluza significantly reduced the time to improvement of flu symptoms versus placebo in people at high risk of complications from the flu (median time 73 hours versus 102 hours; p<0.001).

• Similar efficacy results were seen between Xofluza and oseltamivir in relation to duration of symptoms (median time 54 hours versus 54 hours).
• In subjects infected with type B virus, the median time to improvement of flu symptoms was shorter in the Xofluza group compared to the placebo group (75 hours versus 101 hours respectively).
• Adverse events reported in at least 1% of adult and adolescent subjects treated with Xofluza included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%) and headache (1%). Xofluza was well-tolerated and no new safety signals were identified.