SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has accepted, under Priority Review, the company’s supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods in adult and pediatric patients aged 1 year and older with food allergy.

罗氏集团（SIX:RO，ROG；OTCQX:RHHBY）成员基因泰克（Genentech）今天宣布，美国食品和药物管理局（FDA）已在优先审查下接受该公司针对Xolair®（奥马珠单抗）的补充生物制剂许可证申请（sBLA），以减少过敏反应，包括过敏反应，这可能发生在1岁及以上患有食物过敏的成人和儿科患者意外接触一种或多种食物时。

If approved, people taking Xolair would still need to avoid foods they are allergic to (commonly referred to as “food avoidance”). The filing acceptance is based on positive interim analysis results from Stage 1 of the National Institutes of Health (NIH)-sponsored pivotal Phase III OUtMATCH study evaluating Xolair in patients allergic to peanuts and at least two other common foods.

如果获得批准，服用Xolair的人仍然需要避免他们过敏的食物（通常称为“避免食物”）。申请受理是基于美国国立卫生研究院（NIH）赞助的关键性III期OUtMATCH研究第一阶段的积极中期分析结果，该研究评估了对花生和至少两种其他常见食物过敏的患者中Xolair的情况。

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure. The FDA is expected to make a decision on approval in the first quarter of 2024..

如果获得批准，Xolair将成为第一种减少意外接触多种食物后过敏反应的药物。FDA预计将在2024年第一季度做出批准决定。。

“Despite the significant and growing health burden from food allergies, treatment advances have been limited,” said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. “We are proud to partner with the National Institutes of Health and leading research institutions on this groundbreaking study.

Genentech首席医疗官兼全球产品开发负责人、医学博士Levi Garraway说：“尽管食物过敏给健康带来了巨大且不断增长的负担，但治疗进展有限。”。“我们很荣幸能与美国国立卫生研究院和领先的研究机构合作进行这项开创性的研究。

The FDA’s Priority Review designation acknowledges the unmet need for these patients, and we hope to make Xolair available to as many people as possible living with food allergies in the U.S.”.

FDA的优先审查指定承认这些患者的需求尚未得到满足，我们希望尽可能多的美国食物过敏患者可以使用Xolair”。

At a pre-planned interim analysis, an independent Data and Safety Monitoring Board (DSMB) examined the data on the first 165 children and adolescents aged 1 to 17 years who participated in the first stage of the trial and determined the study met its primary endpoint and key secondary endpoints. These interim results showed that, compared to placebo, Xolair significantly increased the amount of peanut (primary endpoint) and milk, egg and cashew (key secondary endpoints) it took to cause an allergic reaction in children and adolescents with food allergies.

在预先计划的中期分析中，独立数据和安全监测委员会（DSMB）检查了参与试验第一阶段的前165名1至17岁儿童和青少年的数据，并确定该研究符合其主要终点和关键次要终点。这些中期结果表明，与安慰剂相比，Xolair显着增加了花生（主要终点）和牛奶，鸡蛋和腰果（关键次要终点）的含量，这些都是引起食物过敏儿童和青少年过敏反应的原因。

Safety findings were consistent with the known benefit-risk profile of Xolair across its approved indications and in previous clinical trials..

安全性研究结果与Xolair在其批准的适应症和之前的临床试验中已知的益处-风险概况一致。。

The Phase III OUtMATCH study is being sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, and conducted by the NIAID-funded Consortium of Food Allergy Research (CoFAR) across 10 clinical sites throughout the U.S. The study is also supported by Genentech and Novartis Pharmaceuticals Corporation.

这项III期OUtMATCH研究由美国国立卫生研究院（NIH）下属的国家过敏与传染病研究所（NIAID）赞助和资助，并由NIAID资助的食物过敏研究联盟（CoFAR）在全美10个临床地点进行。该研究还得到了基因泰克（Genentech）和诺华制药公司（Novartis Pharmaceuticals Corporation）的支持。

Detailed results from the OUtMATCH study have been submitted by NIAID and CoFAR to a peer-reviewed journal..

NIAID和CoFAR已将OUtMATCH研究的详细结果提交给同行评审期刊。。

Food allergies affect up to 17 million children and adults in the U.S. and food allergy prevalence has been on the rise for the past 20 years. Allergic reactions can range from mild to moderate, including hives and swelling, to severe and life-threatening, such as anaphylaxis. More than 40% of children and more than half of adults with food allergies have experienced a severe reaction at least once, and it is estimated that food-related anaphylaxis results in 30,000 medical events treated in emergency rooms in the U.S.

食物过敏影响了美国多达1700万儿童和成人，食物过敏的患病率在过去20年中一直在上升。过敏反应的范围从轻度到中度，包括荨麻疹和肿胀，到严重和危及生命的过敏反应，例如过敏反应。超过40%的食物过敏儿童和一半以上的成年人至少经历过一次严重反应，据估计，与食物相关的过敏反应导致美国急诊室治疗了30000起医疗事件。

each year..

每年。。

In August 2018, the FDA granted Breakthrough Therapy Designation for Xolair for the prevention of severe allergic reactions following accidental exposure to one or more foods in people with allergies. The FDA’s Breakthrough Therapy Designation is designed to expedite the development and review of drugs that are intended to treat serious conditions.

2018年8月，FDA授予Xolair突破性治疗指定，用于预防过敏患者意外接触一种或多种食物后的严重过敏反应。FDA的突破性治疗指定旨在加速旨在治疗严重疾病的药物的开发和审查。

Xolair is currently FDA-approved for the treatment of moderate to severe persistent allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP). Since its initial approval in 2003, more than 700,000 patients have been treated with Xolair in the U.S..

Xolair目前被FDA批准用于治疗中度至重度持续性过敏性哮喘，慢性自发性荨麻疹（CSU）和慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）。自2003年首次批准以来，美国已有70多万患者接受Xolair治疗。。

In the U.S., Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

在美国，基因泰克和诺华制药公司合作开发和共同推广Xolair。

About the OUtMATCH Study

关于OUtMATCH研究

The Omalizumab as Monotherapy and as Adjunct Therapy to Multi-Allergen Oral Immunotherapy in Food Allergic Children and Adults (OUtMATCH; NCT03881696) study is an NIH-sponsored, three-stage, multicenter, randomized, double-blind, placebo-controlled study evaluating Xolair safety and efficacy in patients aged 1 to 55 years who are allergic to peanuts and at least two other common foods.

奥马珠单抗作为单一疗法和多过敏原口服免疫疗法在食物过敏儿童和成人中的辅助疗法（OUtMATCH；NCT03881696）研究是一项NIH赞助的，三阶段，多中心，随机，双盲，安慰剂对照研究，评估Xolair对花生和至少两种其他常见食物过敏的1至55岁患者的安全性和有效性。

The study includes three stages, of which only Stage 1 has been completed..

这项研究包括三个阶段，其中只有第一阶段已经完成。。

Stage 1 patients were randomized to receive placebo or Xolair injections either every two weeks or every four weeks for 16 to 20 weeks. The Xolair dose and dosing interval were determined by total serum immunoglobulin E (IgE) level and body weight.

第一阶段患者被随机分配接受安慰剂或Xolair注射，每两周或每四周注射一次，持续16至20周。Xolair剂量和给药间隔由总血清免疫球蛋白E（IgE）水平和体重确定。

About Xolair

关于Xolair

In the U.S., Xolair is the only approved antibody designed to target and block IgE. By reducing free IgE, down-regulating high-affinity IgE receptors and limiting mast cell degranulation, Xolair minimizes the release of mediators throughout the allergic inflammatory cascade.

在美国，Xolair是唯一被批准用于靶向和阻断IgE的抗体。通过减少游离IgE，下调高亲和力IgE受体并限制肥大细胞脱粒，Xolair最大程度地减少了整个过敏性炎症级联反应中介质的释放。

Indications and Important Safety Information

指示和重要安全信息

What is XOLAIR?

什么是XOLAIR？

XOLAIR® (omalizumab) for subcutaneous use is an injectable prescription medicine used to treat:

皮下使用的XOLAIR®（奥马珠单抗）是一种可注射处方药，用于治疗：

moderate to severe persistent asthma in people 6 years of age and older whose asthma symptoms are not well controlled with asthma medicines called inhaled corticosteroids. A skin or blood test is performed to see if you have allergies to year-round allergens. It is not known if XOLAIR is safe and effective in people with asthma under 6 years of age..

6岁及以上的人群中，中度至重度持续性哮喘，其哮喘症状不能通过称为吸入性皮质类固醇的哮喘药物得到很好的控制。进行皮肤或血液测试以查看您是否对全年的过敏原过敏。目前尚不清楚XOLAIR对6岁以下哮喘患者是否安全有效。。

chronic rhinosinusitis with nasal polyps (CRSwNP) in people 18 years of age and older when medicines to treat CRSwNP called nasal corticosteroids have not worked well enough. It is not known if XOLAIR is safe and effective in people with CRSwNP under 18 years of age.

慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）发生在18岁及以上的人群中，当时治疗CRSwNP的药物（称为鼻皮质类固醇）效果不佳。目前尚不清楚XOLAIR对18岁以下CRSwNP患者是否安全有效。

chronic spontaneous urticaria (CSU, previously referred to as chronic idiopathic urticaria (CIU), chronic hives without a known cause) in people 12 years of age and older who continue to have hives that are not controlled with H1 antihistamine treatment. It is not known if XOLAIR is safe and effective in people with CSU under 12 years of age..

慢性自发性荨麻疹（CSU，以前称为慢性特发性荨麻疹（CIU），无已知原因的慢性荨麻疹）发生在12岁及以上的人群中，这些人群继续患有不受H1抗组胺治疗控制的荨麻疹。目前尚不清楚XOLAIR对12岁以下CSU患者是否安全有效。。

XOLAIR is not used to treat other allergic conditions, other forms of hives, or sudden breathing problems.

XOLAIR不用于治疗其他过敏性疾病，其他形式的荨麻疹或突然的呼吸问题。

IMPORTANT SAFETY INFORMATION

重要安全信息

What is the most important information I should know about XOLAIR?

关于XOLAIR，我应该知道的最重要的信息是什么？

Severe allergic reaction. A severe allergic reaction called anaphylaxis can happen when you receive XOLAIR. The reaction can occur after the first dose, or after many doses. It may also occur right after a XOLAIR injection or days later. Anaphylaxis is a life-threatening condition and can lead to death.

严重过敏反应。当你服用XOLAIR时，会发生一种称为过敏反应的严重过敏反应。该反应可以在第一次剂量后或多次剂量后发生。它也可能在XOLAIR注射后或几天后发生。过敏反应是一种危及生命的疾病，可导致死亡。

Go to the nearest emergency room right away if you have any of these symptoms of an allergic reaction:.

如果您有任何过敏反应症状，请立即前往最近的急诊室：。

wheezing, shortness of breath, cough, chest tightness, or trouble breathing

喘息、呼吸急促、咳嗽、胸闷或呼吸困难

low blood pressure, dizziness, fainting, rapid or weak heartbeat, anxiety, or feeling of “impending doom”

低血压、头晕、昏厥、心跳加速或微弱、焦虑或“厄运即将来临”的感觉

flushing, itching, hives, or feeling warm

潮红、瘙痒、荨麻疹或感觉温暖

swelling of the throat or tongue, throat tightness, hoarse voice, or trouble swallowing

喉咙或舌头肿胀，喉咙紧绷，声音嘶哑或吞咽困难

Your healthcare provider will monitor you closely for symptoms of an allergic reaction while you are receiving XOLAIR and for a period of time after treatment is initiated. Your healthcare provider should talk to you about getting medical treatment if you have symptoms of an allergic reaction.

您的医疗保健提供者将在您接受XOLAIR治疗期间以及开始治疗后的一段时间内密切监测您的过敏反应症状。如果你有过敏反应的症状，你的医疗保健提供者应该告诉你接受治疗。

Do not receive and use XOLAIR if you are allergic to omalizumab or any of the ingredients in XOLAIR.

如果您对奥马珠单抗或XOLAIR中的任何成分过敏，请不要接受和使用XOLAIR。

Before receiving XOLAIR, tell your healthcare provider about all of your medical conditions, including if you:

在接收XOLAIR之前，请告知您的医疗保健提供者您的所有医疗状况，包括您是否：

have a latex allergy or any other allergies (such as food allergy or seasonal allergies). The needle cap on the XOLAIR prefilled syringe contains a type of natural rubber latex.

有乳胶过敏或任何其他过敏（如食物过敏或季节性过敏）。XOLAIR预充注射器上的针头帽含有一种天然胶乳。

have sudden breathing problems (bronchospasm)

突然出现呼吸问题（支气管痉挛）

have ever had a severe allergic reaction called anaphylaxis

曾经有过严重的过敏反应，称为过敏反应

have or have had a parasitic infection

有或曾经有过寄生虫感染

have or have had cancer

患有或曾经患有癌症

are pregnant or plan to become pregnant. It is not known if XOLAIR may harm your unborn baby.

怀孕或计划怀孕。目前尚不清楚XOLAIR是否会伤害您未出生的婴儿。

are breastfeeding or plan to breastfeed. It is not known if XOLAIR passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby while you receive and use XOLAIR.

正在母乳喂养或计划母乳喂养。不知道XOLAIR是否会进入你的母乳。在您接受和使用XOLAIR时，与您的医疗保健提供者讨论喂养宝宝的最佳方式。

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

告诉你的医疗保健提供者你服用的所有药物，包括处方药和非处方药、维生素和草药补充剂。

How should I receive and use XOLAIR?

我应该如何接收和使用XOLAIR？

When starting treatment XOLAIR should be given by your healthcare provider in a healthcare setting.

当开始治疗时，XOLAIR应由您的医疗保健提供者在医疗保健环境中给予。

If your healthcare provider decides that you or a caregiver may be able to give your own XOLAIR prefilled syringe injections, you should receive training on the right way to prepare and inject XOLAIR.

如果您的医疗保健提供者决定您或护理人员可能能够给您自己的XOLAIR预充注射器注射，您应该接受正确方法的培训，以准备和注射XOLAIR。

Do not try to inject your XOLAIR prefilled syringe until you have been shown the right way to give XOLAIR injections by a healthcare provider. Use XOLAIR exactly as prescribed by your healthcare provider. For children 12 years of age and older, XOLAIR prefilled syringe may be self-injected under adult supervision.

在医疗保健提供者向您展示正确的XOLAIR注射方法之前，不要尝试注射XOLAIR预充注射器。严格按照医疗保健提供者的规定使用XOLAIR。对于12岁及以上的儿童，XOLAIR预充注射器可以在成人监督下自行注射。

For children 6 to 11 years of age, XOLAIR prefilled syringe should be injected by a caregiver..

对于6至11岁的儿童，护理人员应注射XOLAIR预充注射器。。

See the detailed Instructions for Use that comes with XOLAIR for information on the right way to prepare and inject XOLAIR.

有关准备和注入XOLAIR的正确方法的信息，请参阅XOLAIR附带的详细使用说明。

XOLAIR is given in 1 or more injections under the skin (subcutaneous), 1 time every 2 or 4 weeks.

XOLAIR在皮肤下（皮下）注射1次或多次，每2或4周注射1次。

In people with asthma and CRSwNP, a blood test for a substance called IgE must be performed before starting XOLAIR to determine the appropriate dose and dosing frequency.

对于患有哮喘和CRSwNP的患者，在开始使用XOLAIR之前必须进行一种称为IgE的物质的血液测试，以确定适当的剂量和给药频率。

In people with chronic hives, a blood test is not necessary to determine the dose or dosing frequency.

对于慢性荨麻疹患者，不需要进行血液检查来确定剂量或给药频率。

Do not decrease or stop taking any of your other asthma, CRSwNP, or hive medicine unless your healthcare providers tell you to.

除非你的医疗保健提供者告诉你，否则不要减少或停止服用任何其他哮喘，CRSwNP或荨麻疹药物。

You may not see improvement in your symptoms right away after XOLAIR treatment. If your asthma symptoms do not improve or get worse, call your healthcare provider.

XOLAIR治疗后，您可能不会立即看到症状改善。如果您的哮喘症状没有改善或恶化，请致电您的医疗保健提供者。

If you inject more XOLAIR than prescribed, call your healthcare provider right away.

如果您注射的XOLAIR超过规定量，请立即致电您的医疗保健提供者。

What are the possible side effects of XOLAIR?

XOLAIR可能有哪些副作用？

XOLAIR may cause serious side effects, including:

XOLAIR可能会引起严重的副作用，包括：

Cancer. Cases of cancer were observed in some people who received XOLAIR.

癌症。在一些接受XOLAIR的人中观察到癌症病例。

Inflammation of your blood vessels. Rarely, this can happen in people with asthma who receive XOLAIR. This usually, but not always, happens in people who also take a steroid medicine by mouth that is being stopped or the dose is being lowered. It is not known whether this is caused by XOLAIR. Tell your healthcare provider right away if you have rash; chest pain; shortness of breath; or a feeling of pins and needles or numbness of your arms or legs..

血管发炎。这种情况很少发生在接受XOLAIR治疗的哮喘患者身上。这种情况通常（但不总是）发生在口服类固醇药物的人身上，这种药物正在停止或剂量正在降低。目前尚不清楚这是否是由XOLAIR引起的。如果你有皮疹，立即告诉你的医疗保健提供者；胸痛；呼吸急促；或是针扎的感觉，或是手臂或腿部麻木的感觉。。

Fever, muscle aches, and rash. Some people get these symptoms 1 to 5 days after receiving a XOLAIR injection. If you have any of these symptoms, tell your healthcare provider.

发烧、肌肉酸痛和皮疹。一些人在接受XOLAIR注射后1至5天出现这些症状。如果您有任何这些症状，请告诉您的医疗保健提供者。

Parasitic infection. Some people who are at a high risk for parasite (worm) infections, get a parasite infection after receiving XOLAIR. Your healthcare provider can test your stool to check if you have a parasite infection.

寄生虫感染。一些寄生虫（蠕虫）感染风险高的人在服用XOLAIR后会感染寄生虫。您的医疗保健提供者可以检测您的粪便，以检查您是否感染了寄生虫。

Heart and circulation problems. Some people who receive XOLAIR have had chest pain, heart attack, blood clots in the lungs or legs, or temporary symptoms of weakness on one side of the body, slurred speech, or altered vision. It is not known whether these are caused by XOLAIR.

心脏和循环问题。一些接受XOLAIR治疗的人有胸痛、心脏病发作、肺部或腿部血栓形成，或身体一侧暂时无力、言语含糊或视力改变的症状。目前尚不清楚这些是否是由XOLAIR引起的。

The most common side effects of XOLAIR:

XOLAIR最常见的副作用是：

In adults and children 12 years of age and older with asthma: joint pain especially in your arms and legs, dizziness, feeling tired, itching, skin rash, bone fractures, and pain or discomfort of your ears.

患有哮喘的12岁及以上的成人和儿童：关节疼痛，尤其是四肢疼痛，头晕，疲倦，瘙痒，皮疹，骨折以及耳朵疼痛或不适。

In children 6 to less than 12 years of age with asthma: swelling of the inside of your nose, throat, or sinuses, headache, fever, throat infection, ear infection, abdominal pain, stomach infection, and nose bleeds.

6至12岁以下哮喘患儿：鼻子、喉咙或鼻窦内部肿胀，头痛、发烧、喉咙感染、耳朵感染、腹痛、胃感染和鼻子出血。

In adults with chronic rhinosinusitis with nasal polyps: headache, injection site reactions, joint pain, upper abdominal pain, and dizziness.

患有慢性鼻-鼻窦炎和鼻息肉的成年人：头痛，注射部位反应，关节痛，上腹痛和头晕。

In people with chronic spontaneous urticaria: nausea, headaches, swelling of the inside of your nose, throat or sinuses, cough, joint pain, and upper respiratory tract infection.

慢性自发性荨麻疹患者：恶心、头痛、鼻子、喉咙或鼻窦内侧肿胀、咳嗽、关节痛和上呼吸道感染。

These are not all the possible side effects of XOLAIR. Call your doctor for medical advice about side effects.

这些并不是XOLAIR所有可能的副作用。打电话给你的医生，询问有关副作用的医疗建议。

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555 or Novartis Pharmaceuticals Corporation at (888) 669-6682.

您可以通过（800）FDA-1088或www.FDA.gov/medwatch向FDA报告副作用。您也可以通过（888）835-2555或诺华制药公司（888）669-6682向Genentech报告副作用。

Please see full Prescribing Information, including Medication Guide for additional Important Safety Information and Instructions for Use.

有关其他重要的安全信息和使用说明，请参阅完整的处方信息，包括药物指南。

About Genentech

关于基因泰克

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

基因泰克成立于40多年前，是一家领先的生物技术公司，负责发现、开发、制造和商业化药物，用于治疗严重威胁生命的患者。该公司是罗氏集团的成员，总部位于加利福尼亚州南旧金山。

For additional information about the company, please visit http://www.gene.com..

有关该公司的更多信息，请访问http://www.gene.com..