FDA 批准了一种新的口服药物 Rhapsido,用于对抗组胺药无反应的慢性荨麻疹成人。
The FDA approved Rhapsido, a new oral drug, for adults with chronic hives unresponsive to antihistamines.
美国食品和药物管理局批准了诺华公司以Rhapsido的名称销售的雷米布鲁丁尼布作为第一种口服布鲁顿斯氨酸激酶抑制剂,用于不对标准抗组胺药物反应的慢性自发性疹患者.
The FDA has approved remibrutinib, sold as Rhapsido by Novartis, as the first oral Bruton’s tyrosine kinase inhibitor for adults with chronic spontaneous urticaria who don’t respond to standard antihistamines.
每天两次的药丸通过靶向肥大细胞活性来减少荨麻疹、瘙痒和肿胀,在临床试验中在 12 周内显着改善症状,并持续长达一年。
The twice-daily pill reduces hives, itching, and swelling by targeting mast cell activity, with significant symptom improvement seen in clinical trials within 12 weeks and lasting up to a year.
近一半的病人达到最低程度或没有症状,该药物显示出一种有利的安全性特征,其副作用大多轻微。
Nearly half of patients achieved minimal or no symptoms, and the drug showed a favorable safety profile with mostly mild side effects.