英国药品监管机构周五批准了强生公司针对中重度斑块状银屑病成人及青少年患者的每日一片口服药物，该皮肤病会导致红色、脱屑且常伴有瘙痒或疼痛的斑块。
以下是详细信息：英国药品和医疗产品监管局（MHRA）批准口服药物 Icotyde 用于年龄在 12 岁及以上、体重至少 40 公斤的患者。
该批准基于 4 项涉及 2500 名患者的晚期临床试验，其中包括 72 名 12 至 18 岁以下的青少年。
Britain's medicines regulator on Friday approved Johnson & Johnson's daily pill for adults and teenagers with moderate-to-severe plaque psoriasis, a skin condition causing red, scaly and often itchy or painful patches.
监管机构表示，在所有 4 项研究中，服用该药物的患者在 16 周后的疗效均优于接受安慰剂的患者。
Icotyde 今年早些时候已在美国获批用于同一适应症——这是其首个获批适应症。
该药物由强生与 Protagonist Therapeutics（PTGX.O）合作开发。
Here are some details:
强生还在研究该药物（化学名为 icotrokinra）治疗溃疡性结肠炎、银屑病关节炎和克罗恩病的疗效。
公司预计该疗法在多个适应症上的峰值销售额将达到 50 亿美元。
该药物将与百时美施贵宝（BMY.N）的 Sotyktu 和艾伯维（ABBV.N）的重磅药物 Skyrizi 等成熟银屑病治疗药物展开竞争。
The Medicines and Healthcare products Regulatory Agency (MHRA) approved the oral drug Icotyde for people aged 12 and older who weigh at least 40 kg The approval was based on four late-stage trials in 2,500 people with the disease, including 72 teenagers aged 12 to under 18 In all four studies, patients who took the drug saw better results after 16 weeks than those given a placebo, the regulator said Icotyde was approved in the US earlier this year for the same condition — its first approved indication The drug is made in collaboration with Protagonist Therapeutics (PTGX.O) J&J is also studying the drug, chemically known as icotrokinra, for ulcerative colitis, psoriatic arthritis and Crohn's disease The company expects the treatment to bring in $5 billion in peak sales across multiple indications The drug competes with established psoriasis treatments such as Bristol Myers Squibb's (BMY.N) Sotyktu and AbbVie's blockbuster (ABBV.N) Skyrizi