Roche could be just months away from an FDA approval of Gazyva as the first anti-CD20 therapy for systemic lupus erythematosus (SLE), a debilitating autoimmune disease affecting millions of people around the world.

罗氏可能仅需数月就能获得FDA批准，将Gazyva作为首个用于治疗系统性红斑狼疮（SLE）的抗CD20疗法。系统性红斑狼疮是一种影响全球数百万人的衰竭性自身免疫疾病。

Already approved for SLE patients who have a serious inflammation of the kidneys known as lupus nephritis in the US and Europe, Gazyva (obinutuzumab) – which is sold as Gazyvaro in some markets – is now under FDA review as a treatment option for all SLE patients.

在美国和欧洲，Gazyva（奥比妥珠单抗，某些市场中销售为 Gazyvaro）已被批准用于治疗患有严重肾脏炎症（称为狼疮性肾炎）的系统性红斑狼疮（SLE）患者，现在该药物正在接受 FDA 审查，作为针对所有 SLE 患者的治疗选择。

Around half of people living with SLE will develop lupus nephritis within five years, so extending Gazyva's use into the wider SLE population could lead to earlier use of the drug and, potentially, prevent patients from developing kidney complications.

大约一半的系统性红斑狼疮患者会在五年内发展为狼疮性肾炎，因此将Gazyva的使用扩展到更广泛的系统性红斑狼疮人群，可能会导致该药物的早期使用，并且可能预防患者出现肾脏并发症。

The FDA will cast its eyes over the results of the

FDA将审视结果的

ALLEGORY

寓言

trial, which revealed that treatment with Gazyva was associated with a significant reduction in disease activity compared with placebo, measured using the SLE Responder Index 4 (SRI-4) scale at 52 weeks, when added to standard therapy like corticosteroids and immunosuppressant drugs.

试验显示，与安慰剂相比，加用Gazyva治疗可显著降低疾病活动性，这一结果是通过在52周时使用系统性红斑狼疮反应指数4（SRI-4）量表测量得出的，且该治疗是在标准疗法（如皮质类固醇和免疫抑制药物）基础上进行的。

An SRI-4 response was observed in 76.7% of the patients in the Gazyva group and in 53.5% of the control group, and the anti-CD20 therapy also scored significantly better on secondary endpoints, looking at the time to the first flare in symptoms and the ability to taper steroid use.

Gazyva组76.7%的患者和对照组53.5%的患者观察到SRI-4反应，而且抗CD20疗法在次要终点上也表现得显著更好，包括症状首次恶化的时间和减少类固醇使用的能力。

Roche has said that the results of the 303-patient study, published in the

罗氏表示，这项针对303名患者的研究结果已发表在

New England Journal of Medicine

新英格兰医学杂志

last month, could position Gazyva as the new standard of care for SLE. The drug has also been submitted for approval in the EU as an SLE therapy.

上个月，Gazyva 可能成为 SLE 的新护理标准。该药物也已提交欧盟批准作为 SLE 疗法。

'For people living with SLE, the daily challenges of the disease can be both physically and emotionally overwhelming,' said Albert T Roy, president and chief executive of the Lupus Research Alliance.

“对于患有系统性红斑狼疮（SLE）的人来说，这种疾病每天带来的挑战可能在身体和情感上都是难以承受的，”狼疮研究联盟主席兼首席执行官阿尔伯特·T·罗伊表示。

'We are hopeful for the approval of Gazyva as a new treatment for SLE, given its potential to manage symptoms as well as drive higher rates of clinical remission and reduce the frequency of debilitating flares.'

“我们对Gazyva作为系统性红斑狼疮（SLE）新疗法的获批充满希望，因为它有潜力控制症状，提高临床缓解率，并减少令人虚弱的复发频率。”

If approved, it will join other biologic therapies for SLE, which include GSK's BLyS inhibitor

如果获得批准，它将与其他用于治疗系统性红斑狼疮（SLE）的生物疗法一同使用，其中包括GSK的BLyS抑制剂。

Benlysta

贝利木单抗

(belimumab), which grew 26% to nearly $2.4 billion last year, and AstraZeneca's type I interferon receptor antagonist Saphnelo (anifrolumab), which brought in $686 million, a rise of 44%.

（贝利木单抗），去年增长了26%，接近24亿美元，以及阿斯利康的I型干扰素受体拮抗剂Saphnelo（anifrolumab），收入达6.86亿美元，增长了44%。

Roche recorded around $1.26 billion in Gazyva sales for the drug last year, and analysts at GlobalData have previously said that approval for SLE could help drive sales to $1.7 billion or more by the end of the decade.

罗氏去年记录的Gazyva药物销售额约为12.6亿美元，GlobalData的分析师此前曾表示，系统性红斑狼疮（SLE）适应症的批准可能有助于推动该药物的销售额在本十年末达到17亿美元或更多。

Other therapies for lupus and its complications are coming through the industry pipeline, including Johnson & Johnson's FcRn blocker nipocalimab, Biogen's BDCA2-targeted litifilimab and anti-CD40L antibody dapirolizumab pegol (DZP), and Merck KGaA's oral TLR7/8 inhibitor enpatoran, all of which are in late-stage clinical testing..

其他针对狼疮及其并发症的疗法正在行业管道中推进，包括强生的FcRn阻断剂nipocalimab、Biogen的BDCA2靶向litifilimab和抗CD40L抗体dapirolizumab pegol（DZP），以及默克KGaA的口服TLR7/8抑制剂enpatoran，所有这些都处于晚期临床试验阶段。