美国食品和药物管理局扩大了Rinvoq的批准范围,用于治疗已经尝试其他治疗方法的成年人发性结肠炎和克罗恩氏病.
FDA expands Rinvoq approval for ulcerative colitis and Crohn’s in adults who’ve tried other treatments.
林业发展局扩大了对AbbVie的药物Rinvoq(upadacitinib)的核准范围,以治疗中度至严重活跃的结肠炎和克罗恩病的成年人,他们至少尝试过其他一种系统疗法,包括TNF阻塞剂不合适的病例。
The FDA has expanded approval for AbbVie’s drug Rinvoq (upadacitinib) to treat adults with moderately to severely active ulcerative colitis and Crohn’s disease who have tried at least one other systemic therapy, including cases where TNF blockers aren’t suitable.
先前只允许那些对TNF抑制剂没有反应或无法忍受的病人使用,
Previously approved only for patients who didn’t respond to or couldn’t tolerate TNF inhibitors, the update allows earlier use.
该药物是日本药管局的抑制剂,针对的是发炎途径,但具有严重的安全风险,包括感染、血液凝块和癌症,特别是在有心脏病风险因素或吸烟者的老年人中。
The drug, a JAK inhibitor, targets inflammation pathways but carries serious safety risks, including infections, blood clots, and cancer, especially in older adults with heart disease risk factors or smokers.