葛蘭素史克向美國FDA申請把RSV疫苗使用範圍擴至50歲以下高風險成年人
英國藥廠葛蘭素史克(GSK)已向美國食品及藥物管理局(FDA)提交申請,將其呼吸道合胞病毒(RSV)疫苗Arexvy的使用範圍擴至50歲以下高風險成年人。預計美國當局將在明年上半年作出決定。歐洲監管機構亦預計屆時將對類似申請作出決定。
若獲得批准,該藥將與莫德納(MRNA.US)mRESVIA和輝瑞(PFE.US)Abrysvo競爭。Arexvy目前在美國獲准用於60歲及以上長者以及50至59歲高風險成年人。該疫苗銷量落後競爭對手。
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