After a couple of days filled with investor nervousness, Arcutis Biotherapeutics has claimed FDA approval of Zoryve for the new indication of atopic dermatitis (AD), a common form of eczema.The FDA had been due to give its verdict on the Zoryve (roflumilast) for the new use on the 7th of this month, but the date came and went.

在投资者紧张不安的几天后，Arcutis Biotherapeutics宣布FDA批准Zoryve用于特应性皮炎（AD）的新适应症，AD是湿疹的一种常见形式。FDA本应于本月7日对Zoryve（罗氟司特）的新用途作出裁决，但日期来了又去。

In an unusual attempt to quell shareholder jitters, Arcutis issued a statement yesterday saying there had been no request for new information and it was expecting a letter from the regulator soon.Later on in the day, confirmation finally came in – Zoryve had been approved as a new, once-daily treatment for mild to moderate atopic dermatitis in adults and children six years of age and older, adding to its earlier indications in plaque psoriasis and another form of eczema called seborrheic dermatitis that mainly affects the scalp.

为了平息股东的不安情绪，阿库蒂斯（Arcutis）昨日发表声明称，没有要求提供新信息，预计监管机构很快会发出一封信。当天晚些时候，终于得到了确认——Zoryve已被批准作为一种新的每日一次的治疗方法，用于治疗6岁及以上的成人和儿童的轻度至中度特应性皮炎，这增加了其早期对斑块状牛皮癣和另一种称为脂溢性皮炎的湿疹的适应症，这种湿疹主要影响头皮。

There’s no indication why the delay took place.The topical phosphodiesterase 4 inhibitor has been cleared on the back of phase 3 data showing that 91.5% of patients treated for atopic dermatitis experienced a measurable improvement in Eczema Area and Severity Index (EASI) after four weeks.The drug offers a new option for patients that can be used anywhere on the body – unlike corticosteroids that cannot be used on the face – with a once-daily application.

没有迹象表明为什么会发生延误。第三阶段数据显示，91.5%的特应性皮炎患者在四周后湿疹面积和严重程度指数（EASI）有明显改善，局部磷酸二酯酶4抑制剂已被清除。这种药物为患者提供了一种新的选择，可以在身体的任何地方使用-不像不能在脸上使用的皮质类固醇-每天一次。

It can also be used for any duration, also unlike steroids which are known to cause skin thinning with protracted use.The phase 3 INTEGUMENT programme also found that the drug achieved a significant reduction in itch, the most bothersome symptom of atopic dermatitis, with 69% of patients demonstrating a clinically meaningful improvement at four weeks and some seeing relief within 24 hours.“Topical steroids have been the foundation of treatment for atopic dermatitis for th.

它也可以用于任何时间，也不同于已知长期使用会导致皮肤变薄的类固醇。第三阶段皮肤计划还发现，该药物显着降低了特应性皮炎最令人烦恼的症状瘙痒，69%的患者在四周时表现出临床上有意义的改善，一些患者在24小时内缓解。“局部类固醇是治疗th特应性皮炎的基础。