UCB, a global biopharmaceutical company,  announced the CHMP (Committee for Medicinal Products for Human Use) has issued a positive opinion for the self-administration of Rystiggo (rozanolixizumab) via an infusion (syringe pump) or a new manual push syringe method, after training from a healthcare professional. .

全球生物制药公司UCB宣布，CHMP（人类使用药品委员会）在接受医疗保健专业人员的培训后，通过输液（注射泵）或新的手动推注注射器方法，对Rystiggo（rozanolixizumab）的自我管理发表了积极的意见。。

In the EU, rozanolixizumab is indicated as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive.

在欧盟，rozanolixizumab被指定为标准疗法的附加品，用于治疗抗乙酰胆碱受体（AChR）或抗肌肉特异性酪氨酸激酶（MuSK）抗体阳性的成年患者的全身性重症肌无力（gMG）。

“For people living with gMG, unpredictable symptoms can have a significant impact on daily life, leading to patients feeling vulnerable and lacking control. Subcutaneous self-administration may help address these challenges, enhancing patient autonomy and satisfaction by reducing the need for frequent clinic visits,” said Donatello Crocetta, Chief Medical Officer and Head of Global Medical Affairs, UCB.

“对于患有gMG的人来说，不可预测的症状可能会对日常生活产生重大影响，导致患者感到脆弱和缺乏控制。皮下自我管理可能有助于应对这些挑战，通过减少频繁就诊的需要来提高患者的自主权和满意度，”UCB首席医疗官兼全球医疗事务负责人多纳泰罗·克罗切塔（DonatelloCrocetta）说。

“We welcome the EU approval for self-administration of rozanolixizumab in Europe, marking another significant step forward in our ongoing commitment to improving the lives of people living with gMG.”  .

“我们欢迎欧盟批准rozanolixizumab在欧洲的自我管理，这标志着我们正在致力于改善gMG患者生活的另一个重要步骤。”。

This approval is based on several studies, including a Phase III, open-label, crossover study to evaluate the ability of patients with generalized myasthenia gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

该批准基于多项研究，包括一项III期开放标签交叉研究，以评估全身性重症肌无力（gMG）患者在使用注射器驱动器和手动推注方法进行自我管理技术培训后成功自我管理罗扎尼昔单抗的能力。

The manual push method allows administration at a flow rate that is comfortable for the patient to accommodate individual preferences. In clinical trials, infusion times by manual push for rozanolixizumab ranged from 1 to 30 minutes with a median infusion time of just 5 minutes per patient. This range of infusion times may serve as a guide when training the patient or caregiver..

手动推送方法允许以患者舒适的流速给药，以适应个人偏好。在临床试验中，手动推注罗扎尼昔单抗的输注时间为1至30分钟，每位患者的中位输注时间仅为5分钟。在培训患者或护理人员时，此输注时间范围可作为指导。。

Self-administration of rozanolixizumab is also being reviewed by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), reflecting UCB's global efforts to address the diverse, unmet needs of the gMG community.

rozanolixizumab的自我管理也正在接受日本药品和医疗器械管理局（PMDA）的审查，这反映了UCB在全球范围内努力解决gMG社区的各种未满足需求。

Currently, rozanolixizumab is administered by the patient’s clinician as a subcutaneous infusion once weekly for six weeks using infusion pump/syringe pumps, and the recommended total weekly dose of rozanolixizumab is based on the patient’s body weight.

目前，罗扎诺利昔单抗由患者的临床医生使用输液泵/注射泵每周皮下输注一次，持续六周，推荐的罗扎诺利昔单抗每周总剂量基于患者的体重。

Condition:

条件：

Myasthenia Gravis

Type:

类型：

drug

药物