预约演示
AbbVie’s SKYRIZI gains US FDA approval for ulcerative colitis
临床3期引进/卖出上市批准并购临床结果
Post-induction, patients have the option to self-administer SKYRIZI at home using an on-body injector. Credit: Copyright © 2024 AbbVie Inc. North Chicago, Illinois, U.S.A.
AbbVie has announced receipt of US Food and Drug AdministratSKYRIZIA) approval for SKYRIZI (risankizumab-rzaa) to treat adult paAbbVie Inc. moderately to severely active ulcerative colitis.
AbbVieI is the first IL-23 inhibUS Food and Drug Administration (FDA) to severe ulcSKYRIZI crisankizumab-rzaas disease indications, broadening its therapeutic reacactive ulcerative colitisisease (IBD).
SKYRIZIroved regimen IL-23 inhibitorIL-23KYRIZI offers an induction period of 12 weeks with thrulcerative colitisministered every four weeks. Maintenance therapy is then prescribed atinflammatory bowel disease (IBD)ht weeks.
Post-induction, patients SKYRIZIe option to self-administer SKYRIZI at home using an on-body injector.
The approval is grounded in results from two pivotal Phase ISKYRIZIical trials: INSPIRE and COMMAND, in moderate to severe ulcerative colitis patients.
See Also:FDA grants approval for Alexion’s NMOSD treatmentulcerative colitis
INSPIRE was a randomised, multicentre, double-blind, placebo-controlled trial that focused on the safety and efficacy of a 1200mg intravenous dose of risankizumab, given every four weeks as induction therapy in people with active ulcerative colitis.
AbbVieMMAND study was designed to Landos Biopharmaety and efficacy of risankizumab at doses of 180mg or 360mg subcutaneously in adults with the same condition over 52 weeks as maintenance therapy.
Both trials met their primary endpoint of clinical remission and reported significant endoscopic improvement, a crucial secondary endpoint.
Risankizumab, marketed as SKYRIZI, is the product of a collaborative effort between Boehringer Ingelheim and AbbVie. AbbVie is responsible for the glorisankizumabalisation and further development of the therapy.active ulcerative colitis
AbbVie global therapeutics senior vice-president and chief medical offrisankizumabThakkar stated: “The approval of SKYRIZI for ulcerative colitis expands our IBD portfolio and demonstrates our commitment to helping address ongoing needs of patients.
“We will continue to invest in transforming the treatment landscape and the lives of people suffering from lBD.”
Risankizumabevelopment comSKYRIZIr AbbVie entered into a licence agreement with FutuBoehringer Ingelheimcal tAbbVieloAbbVie701 for IBD.
更多内容，请访问原始网站
文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。
靶点
生物医药百科问答
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。