Otsuka Pharmaceutical have announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for sibeprenlimab for priority review.

大冢制药宣布，美国食品药品监督管理局（FDA）已接受sibeprenlimab的生物制品许可申请（BLA），并给予优先审查。

Sibeprenlimab has already received Breakthrough Therapy designation from the FDA, supported by favourable outcomes from the Phase 2 trial. The therapy is intended to help reduce Gd-IgA1 levels, which are central to the formation of harmful immune complexes. By lowering these levels and inhibiting APRIL, sibeprenlimab may help to limit immune-mediated kidney damage and slow disease progression..

Sibeprenlimab 已经获得 FDA 的突破性疗法认定，得到了二期试验良好结果的支持。该疗法旨在帮助降低 Gd-IgA1 水平，这对于有害免疫复合物的形成至关重要。通过降低这些水平并抑制 APRIL，Sibeprenlimab 可能有助于限制免疫介导的肾脏损伤并减缓疾病进展。

IgAN primarily affects adults between the ages of 20 and 40. It is a long-term disease that gradually leads to end-stage kidney disease (ESKD) in many patients, often requiring dialysis or transplantation. Existing treatments mainly offer supportive care, and there remains a pressing need for disease-specific therapies that target underlying mechanisms..

IgAN主要影响20至40岁之间的成年人。它是一种长期疾病，许多患者会逐渐发展为终末期肾病（ESKD），通常需要透析或移植。现有治疗主要提供支持性护理，仍然迫切需要针对潜在机制的特定疾病疗法。

APRIL is part of the tumour necrosis factor (TNF) family and plays a key role in supporting B-cell function and IgA production, particularly Gd-IgA1. Inhibiting APRIL could therefore help disrupt the disease pathway in IgAN and improve long-term outcomes for affected individuals.

APRIL是肿瘤坏死因子（TNF）家族的一部分，在支持B细胞功能和IgA生成（尤其是Gd-IgA1）中起关键作用。因此，抑制APRIL可能有助于破坏IgAN的疾病通路，并改善受影响个体的长期预后。

The investigational therapy is intended for the treatment of immunoglobulin A nephropathy (IgAN), a progressive autoimmune kidney disease.

该研究性疗法旨在治疗免疫球蛋白A肾病（IgAN），一种进展性的自身免疫性肾脏疾病。

Sibeprenlimab is a monoclonal antibody designed to target and inhibit APRIL (A Proliferation-Inducing Ligand), a cytokine involved in the disease’s development. IgAN is driven by a process known as the '4-hit' model, where abnormal IgA (galactose-deficient IgA1 or Gd-IgA1) is produced and leads to immune complex formation.

西贝普伦利单抗是一种单克隆抗体，旨在靶向并抑制APRIL（增殖诱导配体），这是一种与疾病发展相关的细胞因子。IgAN由被称为“四打击”模型的过程驱动，其中异常的IgA（缺乏半乳糖的IgA1或Gd-IgA1）被产生并导致免疫复合物形成。

These complexes build up in the kidneys, resulting in inflammation and eventual loss of kidney function..

这些复合物在肾脏中积聚，导致炎症并最终导致肾功能丧失。

The treatment is formulated for subcutaneous self-administration once every four weeks using a single-dose prefilled syringe, offering patients greater flexibility and convenience.

该治疗方案采用单剂量预充式注射器，每四周一次皮下自我给药，为患者提供了更大的灵活性和便利性。

With the FDA granting priority review, the Prescription Drug User Fee Act (PDUFA) date has been set for 28 November 2025.

由于FDA授予优先审查，处方药用户收费法案（PDUFA）的日期已定为2025年11月28日。

Source: otsuka.co.jp

来源：otsuka.co.jp