Precigen has received approval from the US Food and Drug Administration (FDA) for PAPZIMEOS™ (zopapogene imadenovec-drba), the first authorised treatment for adults with recurrent respiratory papillomatosis (RRP).

Precigen公司已获得美国食品药品监督管理局（FDA）批准的PAPZIMEOS™（佐帕基因伊马德诺维克-drba），这是首个获准用于治疗成人复发性呼吸道乳头状瘤病（RRP）的疗法。

PAPZIMEOS is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen derived from human papillomavirus (HPV) types 6 and 11, which are the underlying cause of RRP. The therapy is administered through four subcutaneous injections over a 12-week period.

PAPZIMEOS是一种基于非复制型腺病毒载体的免疫疗法，旨在表达源自人乳头瘤病毒（HPV）6型和11型的融合抗原，这些病毒是导致RRP的根本原因。该疗法通过在12周内进行四次皮下注射来施用。

RRP is a rare and chronic disease of the respiratory tract caused by persistent HPV 6 or HPV 11 infection. The condition can result in severe voice problems, airway obstruction, recurrent infections, and in some cases progression to cancer. Current management has largely depended on repeated surgeries to remove growths, a process associated with high patient and healthcare burden as well as long-term risks..

RRP 是一种由持续的 HPV 6 或 HPV 11 感染引起的罕见且慢性的呼吸道疾病。该病可能导致严重的声音问题、气道阻塞、反复感染，甚至在某些情况下会发展为癌症。目前的治疗方法主要依赖于反复手术切除增生组织，这一过程对患者和医疗系统都带来了沉重负担，并伴随着长期风险。

This marks the first time a therapy addressing the root cause of the condition has been made available, ending reliance on repeated surgical procedures.

这标志着首次提供针对该疾病根源的治疗方法，结束了依赖反复手术的局面。

The FDA decision is based on results from a pivotal open-label study in adults with RRP. The study achieved its primary safety and efficacy goals. Findings showed that 51% of patients (18 out of 35) achieved a complete response, with no surgeries required in the 12 months following treatment. Of these, the majority maintained this response for over two years.

FDA 的决定基于一项针对 RRP 成人患者的关键开放标签研究结果。该研究达到了其主要的安全性和有效性目标。研究结果显示，51% 的患者（35 人中的 18 人）实现了完全缓解，在治疗后的 12 个月内无需手术。其中，大多数人保持这种效果超过两年。

PAPZIMEOS was well tolerated, with no severe treatment-related adverse events reported. The therapy also demonstrated the ability to trigger HPV 6/11-specific immune responses, particularly in patients who responded to treatment..

PAPZIMEOS 耐受性良好，未报告严重的治疗相关不良事件。该疗法还显示出能够触发 HPV 6/11 特异性免疫反应的能力，尤其是在对治疗有反应的患者中。

Precigen plans immediate commercial launch of PAPZIMEOS in the United States. A dedicated support programme has been introduced to help patients gain access, including services related to insurance, financial support, and ongoing treatment guidance.

Precigen计划立即在美国商业推出PAPZIMEOS。公司已推出专门的支持计划，以帮助患者获得该药物的使用机会，包括与保险、财务支持及持续治疗指导相关的服务。

The company estimates that around 27,000 adults in the United States are affected by RRP. The approval of PAPZIMEOS is expected to significantly reduce the need for repeated surgical procedures and provide long-term improvements in patient outcomes.

据该公司估计，美国约有 27,000 名成年人受到 RRP 的影响。PAPZIMEOS 的获批有望显著减少对重复手术的需求，并为患者带来长期的疗效改善。

Source: precigen.com

来源：precigen.com