一年只需给药两次 葛兰素史克的重磅哮喘药获美国FDA批准

Core Viewpoint - GlaxoSmithKline's drug Exdensur has received FDA approval for use as an additional maintenance treatment for patients aged 12 and older with severe asthma, positioning it as a potential blockbuster product [1][2]. Group 1: Regulatory Approvals - The FDA has approved Exdensur for severe asthma treatment, and it has also received support from the European Medicines Agency and the UK regulatory body [1][2]. - Regulatory approvals are currently pending in China and Japan [1][2]. Group 2: Market Performance - GlaxoSmithKline's stock rose by 1.2% in early London trading, with a cumulative increase of over 35% year-to-date as of Tuesday's close [3]. Group 3: Product Details - Exdensur, also known as depemokimab, is the first ultra-long-acting biologic for respiratory diseases, requiring administration only twice a year [3]. - Clinical trials have shown that Exdensur can reduce severe asthma attacks by 54% and improve nasal obstruction in chronic sinusitis patients while reducing nasal polyps [3]. - The company anticipates that Exdensur could generate annual sales of up to £3 billion (approximately $4 billion) [3].