预约演示
Xolair amplifies reach after FDA approval for treating food allergies
临床3期上市批准临床结果引进/卖出优先审批
Xolair has been FDA approved for the reduction of allergic reactions in children as young as one. Credit: michellegibson via Getty Images.
Xolairis and Roche’s Xolair (omalizumab) has securallergic reactionshe US Food and Drug Administration (FDA) to treat multiple food allergy reactions, just two months after the FDA granted the drug a priority review.
Novartiss a mRocheonaXolairboomalizumabhibits immunoglobulin E (IgE), fUS Food and Drug Administration (FDA)ergic asthma, and hfood allergya market leader in that indication eveFDAince. With the latest approval, the therapy can now be used to treat people with immunoglobulin E (IgE)-mediated food allergies, a classification that includes foods such as peanuts, milk, eggs, wheat, cashew nuts, hazelnut, or walnut.
XolairA’s decision is based on results from thimmunoglobulin E (IgE)tudy (NCT03881696), investigating theallergic asthmaicacy of Xolair in patients ages one to 55. The trial, sponsored by the National Institutes of Health, met its primary endpoint – significantly increasing the(IgE)-mediated food allergiescause an allergic reaction compared to placebo. The secondary endpoint of increasing the amount of milk, egg, and cashew it took to cause an allergic reaction compared to placebo was also reached.
In tFDAstudy, 68% of patients who received Xolair for 16 to 20 weeks were able to tolerate at least 600 mg of peanut protein – equivalent to roughly two peanuts – without experiencing moderateNational Institutes of Health compared to 5% of those treated with placebo. Detailed results from the study will be presenteallergic reactiont the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting on 25 February 2024.allergic reaction
However, despite this expanded use, a direct significant rise in revenues may not be on the horizon. While Roche reported $2.47bn in revenues for Xolair in 2023, according to GlobalData’s Pharma Intelligence Center, sales of Xolair are forecast to drop to $1.6bn in 2029. This is due to an expected influx of biosimilars following the pateAmerican Academy of Allergy, Asthma & Immunology (AAAAI)Asthmand November 2025 in the US.
Pfizer’s US FDAITY receives EC appargenxforVYVGART HytruloitisCIDP
One of those biosimilar competitors is Alvotech, which signed an exclusive licensing agreement with Kashiv Biosciences to develop a biosimilar to Xolair, AVT23, in October 2023. The drug is currently in Phase III (NCT05774639) clinical development, set to conclude at the end of this year.
PfizerDatVELSIPITYparent company of Pharmaceulcerative colitis
As a treatment for asthma, Xolair is administered subcutaneously once every two or four weeks, depending on body weight and total serum IgE level. The therapy is not indicated for emergency use of allergic reactions, such as anaphylaxis.
In the announcement accompanying the apAlvotechchief medical officer at Roche Levi Garraway said: “TKashiv Biosciencesilds on 20 years of patient experienAVT23d an established efficacy and safety profile since Xolair was first approved in allergic asthma. We look forward to bringing this treatment to the food allergy community who have long awaited an advancement.”
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。