一种治疗干燥综合症肺间质纤维化的新药品（尼达尼布）
发表者：干燥综合症网
日期：2020-03-29
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2020年3月9日-勃林格殷格翰公司宣布，美国食品和药物管理局（FDA）批准Ofev®（尼达尼布）作为慢性纤维化间质性肺病（ILD）患者的第一种治疗方法。无法分类的ILD，自身免疫性ILD，慢性过敏性肺炎，结节病，肌炎，干燥综合征，煤工尘肺病和特发性间质性肺炎如特发性非特异性间质性肺炎等，都可能发展为进行性慢性纤维化ILD的疾病之一。
Ofev是一种多靶点酪氨酸激酶抑制剂，可抑制ILD肺纤维化的关键途径，目前被批准用于特发性肺纤维化（IPF），并减缓系统性硬化症相关ILD患者肺功能下降的速度（SSc-ILD），两种类型的ILD。Ofev于2019年10月获得美国FDA针对具有进行性表型的慢性纤维化ILD的突破性治疗指定。这一新批准现在使Ofev可用于慢性纤维化ILD患者，其中肺纤维化继续恶化。
FDA的批准基于INBUILD®试验，这是ILD领域的第一个III期临床试验，根据患者疾病的临床行为而不是主要的临床诊断对患者进行分组。在该试验中，Ofev的安全性和耐受性特征与先前在IPF研究中所见的一致。与安慰剂相比，Ofev治疗患者报告的最常见不良反应大于或等于5%是腹泻，恶心，腹痛，呕吐，肝酶升高，食欲减退，体重减轻，头痛，高血压，鼻咽炎，上呼吸道感染，尿路感染，疲劳和背部疼痛。请参阅下面包含的其他重要安全信息。
“具有进行性表型的慢性纤维化ILD导致呼吸道症状和肺功能恶化，”密歇根大学安阿伯分校密歇根大学肺与重症监护医学系医学教授Kevin Flaherty说，并领导研究者INBUILD试验。“此批准为许多直到今天才获得批准治疗的患者提供了治疗选择。”
间质性肺病包括200多种疾病，这些疾病被归类为罕见疾病，可导致肺纤维化-肺组织的不可逆瘢痕形成，对肺功能产生负面影响。估计18%至32%的ILD患者发生肺纤维化继续恶化的慢性纤维化ILD。
“作为ILD研究领域的领导者，我们完全致力于更好地了解如何治疗这些破坏性疾病，” 勃林格殷格翰公司医学与监管事务高级副总裁Thomas Seck说，Inc.“今天的批准标志着ILD研究取得了重大进展，并且是Ofev批准后6个月内减缓SSc ILD患者肺功能下降速度的重要里程碑。”
肺间质纤维化基金会首席医疗官Greg Cosgrove说：“患有进展型慢性纤维化ILD的患者可能有与其他呼吸系统疾病相似的症状，可能会延误对患者的准确诊断。”“nintedanib的新适应症为医生及其患者（如干燥综合症）提供了治疗选择，因为现在有一种治疗方案可以帮助减缓肺功能的下降。”
关于第三阶段INBUILD试验
INBUILD试验发表在New England Journal of Medicine上，是一项随机，双盲，安慰剂对照，平行组试验，在15个国家的153个地点进行，评估了Ofev的疗效和安全性（150 mg，对于具有进行性表型的慢性纤维化ILD患者，每日两次，超过52周。共评估了663名患者，其中412名（62.1%）在高分辨率CT（HRCT）上具有常见的间质性肺炎（UIP）样模式。患者的随机化基于通过HRCT检测的纤维化模式。通过用力肺活量（FVC）的年下降率评估肺功能，FVC是肺功能的既定测量值。
结果显示，相对于安慰剂，Ofev使一系列患者的肺功能丧失减慢了57%（107 mL/年）。在HRCT上具有UIP样纤维化模式的患者中，结果显示用Ofev与安慰剂治疗减缓了肺功能丧失61%（128.2mL/年）。
在该试验中，Ofev的安全性和耐受性特征与先前在IPF研究中所见的一致，最常见的不良反应是腹泻。
关于Ofev
Ofev已经在美国和75多个国家被批准用于治疗IPF患者。2019年9月，Ofev在美国被批准作为减缓SSc ILD患者肺功能下降速度的第一种也是唯一一种治疗方法。
Ofev患者支持
为了支持开处方药的人，Boehringer Ingelheim开发了OPEN DOORS®-一项全面的患者支持计划，提供广泛的护理，社会资源和财务支持服务。可通过www.ofev.com和1-866-673-6366访问，开放式服务和资源包括：
每周7天，每天24小时获得护士支持
社会资源服务，以确定当地资源，如支持团体和医生预约的交通
协助寻找财政资源以支持获得Ofev
获取有关IPF，SSc ILD和具有进行性表型的慢性纤维化ILD的教育信息
什么是OFEV？
OFEV是一种使用的处方药：
治疗患有称为特发性肺纤维化（IPF）的肺病的人，或治疗患有慢性（持久）间质性肺病的人，其中肺纤维化继续恶化（进展），或减缓系统性硬化相关间质性肺病（SSc-ILD）（也称为硬皮病相关ILD）患者肺功能下降的速度。目前尚不清楚OFEV对儿童是否安全有效。
重要的安全信息
我应该知道OFEV（nintedanib）最重要的信息是什么？
OFEV可能对未出生的婴儿造成伤害，出生缺陷或死亡。女性在服用OFEV时不应怀孕。能够怀孕的女性应在开始治疗前进行妊娠试验，并应在最后一次给药期间和至少3个月内使用高效节育措施。在此期间，与您的医生讨论哪种节育方法适合您。使用激素避孕药的妇女也应使用屏障避孕方法（如男性避孕套或杀精子剂）。如果您怀孕或认为您在服用EV时怀孕，请立即告诉您的医生。
在使用OFEV之前，我应该告诉我的医生什么？
在您服用OFEV之前，请告诉您的医生您的所有医疗状况，包括您是否有：肝脏问题、心脏问题、血栓病史、出血问题或出血问题的家族史、最近在你的胃（腹部）区域进行了手术。
如果你有以下情况，请告诉你的医生：
怀孕或计划怀孕。
母乳喂养或计划母乳喂养。目前尚不清楚OFEV是否会进入您的母乳。服用OFEV时不应该母乳喂养。
是吸烟者。您应该在服用OFEV之前戒烟，并在治疗期间避免吸烟。
告诉你的医生你服用的所有药物，包括处方药和非处方药，维生素和草药补充剂，如圣约翰草。
OFEV可能产生哪些副作用？
OFEV可能会引起严重的副作用,如果您有任何副作用，请立即告诉您的医生，包括：
肝脏问题。不明原因的症状可能包括皮肤变黄或眼睛白色部分（黄疸），深色或棕色（茶色）尿液，胃区（腹部）右上侧疼痛，出血或瘀伤比正常更容易，感到疲倦或食欲不振。在开始使用OFEV之前和治疗期间，您的医生将进行血液检查以检查您的肝脏工作状况。
腹泻，恶心和呕吐。您的医生可能会建议您饮用液体或服用药物来治疗这些副作用。告诉你的医生你是否有这些症状，如果它们没有消失或变得更糟，如果你正在服用非处方泻药，大便软化剂和其他药物或膳食补充剂。
心脏病发作。心脏病的症状可能包括胸痛或压力，手臂，背部，颈部或下颌疼痛，或呼吸短促。
中风的症状可能包括身体一侧的麻木或虚弱，说话困难，头痛或头晕。
出血问题。OFEV可能会增加出血问题的机会。告诉你的医生你是否有不寻常的出血，瘀伤，不愈合的伤口，和/或你是否服用血液稀释剂，包括处方血液稀释剂和非处方阿司匹林。
撕裂胃或肠壁（穿孔）。OFEV可能会增加您胃或肠壁撕裂的机会。告诉你的医生你的胃区是否有疼痛或肿胀。
OFEV最常见的副作用是腹泻，恶心，胃痛，呕吐，肝脏问题，食欲减退，头痛，体重减轻和高血压。
这些并不是OFEV的所有可能副作用。有关详细信息，请咨询您的医生或药剂师。我们鼓励您向FDA报告处方药的负面副作用。
以下为英文原稿：
Ridgefield, Conn., March 9, 2020 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias such as idiopathic non-specific interstitial pneumonia are among the diseases that may develop a progressive form of chronic fibrosing ILD.
Ofev, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD), two types of ILDs. Ofev received Breakthrough Therapy Designation from the U.S. FDA for chronic fibrosing ILDs with a progressive phenotype in October 2019. This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.
The FDA approval is based on the INBUILD® trial, the first Phase III clinical trial in the field of ILDs to group patients based on the clinical behavior of their disease rather than the primary clinical diagnosis. In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies. The most common adverse reactions reported in greater than or equal to five percent in Ofev-treated patients compared to placebo were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decreased, headache, hypertension, nasopharygitis, upper respiratory tract infection, urinary tract infections, fatigue and back pain. Please see additional Important Safety Information included below.
“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”
Interstitial lung diseases encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.
“As a leader in the field of ILD research, we are fully committed to better understanding how to treat these devastating diseases,” said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Today’s approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD.”
“Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients,” said Greg Cosgrove, M.D., chief medical officer, Pulmonary Fibrosis Foundation. “The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function.”
About the Phase III INBUILD trial
The INBUILD trial, which was published in the New England Journal of Medicine, was a randomized, double-blind, placebo-controlled, parallel group trial conducted at 153 sites in 15 countries that evaluated the efficacy and safety of Ofev (150 mg, twice-daily) over 52 weeks in patients with chronic fibrosing ILDs with a progressive phenotype. A total of 663 patients were evaluated, of whom 412 (62.1 percent) had a usual interstitial pneumonia (UIP)-like pattern on high-resolution CT (HRCT). Randomization of patients was based on the fibrotic patterns as detected through HRCT. Lung function was assessed by the annual rate of decline in forced vital capacity (FVC), which is an established measurement of lung function.
Results showed that Ofev slowed the loss of pulmonary function by 57 percent (107 mL/year) across a range of patients relative to placebo. In patients with UIP-like fibrotic pattern on HRCT, results showed that treatment with Ofev-versus placebo slowed the loss of pulmonary function by 61 percent (128.2mL/year).
In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies, with the most common adverse reaction being diarrhea.
About Ofev
Ofev is already approved in the U.S. and more than 75 countries for the treatment of patients living with IPF. In September 2019, Ofev was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD.
Ofev patient support
To support people who are prescribed Ofev, Boehringer Ingelheim has developed OPEN DOORS® – a comprehensive patient support program that provides a broad range of nursing, social resources, and financial support services. Accessible through www.ofev.com and at 1-866-673-6366, OPEN DOORS services and resources include:
Access to nurse support 24 hours a day, 7 days a week
Social resource services to identify local resources, such as support groups and transportation to doctor appointments
Assistance in finding financial resources to support access to Ofev
Access to educational information on IPF, SSc-ILD and chronic fibrosing ILDs with a progressive phenotype
What is OFEV?
OFEV is a prescription medicine used:
to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
or
to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
or
to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
It is not known if OFEV is safe and effective in children.
Important Safety Information
What is the most important information I should know about OFEV (nintedanib)?
OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use highly effective birth control during and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Women using hormonal birth control should also use a barrier method of birth control (such as male condoms or spermicide). If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.
What should I tell my doctor before using OFEV?
Before you take OFEV, tell your doctor about all of your medical conditions, including if you have:
liver problems.
heart problems.
a history of blood clots.
a bleeding problem or a family history of a bleeding problem.
had recent surgery in your stomach (abdominal) area.
Tell your doctor if you:
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.
What are the possible side effects of OFEV?
OFEV may cause serious side effects.
TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:
Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.
Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.
Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
CL-OF-100032 03.2020
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
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Ofev是一种多靶点酪氨酸激酶抑制剂，可抑制ILD肺纤维化的关键途径，目前被批准用于特发性肺纤维化（IPF），并减缓系统性硬化症相关ILD患者肺功能下降的速度（SSc-ILD），两种类型的ILD。Ofev于2019年10月获得美国FDA针对具有进行性表型的慢性纤维化ILD的突破性治疗指定。这一新批准现在使Ofev可用于慢性纤维化ILD患者，其中肺纤维化继续恶化。
FDA的批准基于INBUILD®试验，这是ILD领域的第一个III期临床试验，根据患者疾病的临床行为而不是主要的临床诊断对患者进行分组。在该试验中，Ofev的安全性和耐受性特征与先前在IPF研究中所见的一致。与安慰剂相比，Ofev治疗患者报告的最常见不良反应大于或等于5%是腹泻，恶心，腹痛，呕吐，肝酶升高，食欲减退，体重减轻，头痛，高血压，鼻咽炎，上呼吸道感染，尿路感染，疲劳和背部疼痛。请参阅下面包含的其他重要安全信息。
“具有进行性表型的慢性纤维化ILD导致呼吸道症状和肺功能恶化，”密歇根大学安阿伯分校密歇根大学肺与重症监护医学系医学教授Kevin Flaherty说，并领导研究者INBUILD试验。“此批准为许多直到今天才获得批准治疗的患者提供了治疗选择。”
间质性肺病包括200多种疾病，这些疾病被归类为罕见疾病，可导致肺纤维化-肺组织的不可逆瘢痕形成，对肺功能产生负面影响。估计18%至32%的ILD患者发生肺纤维化继续恶化的慢性纤维化ILD。
“作为ILD研究领域的领导者，我们完全致力于更好地了解如何治疗这些破坏性疾病，” 勃林格殷格翰公司医学与监管事务高级副总裁Thomas Seck说，Inc.“今天的批准标志着ILD研究取得了重大进展，并且是Ofev批准后6个月内减缓SSc ILD患者肺功能下降速度的重要里程碑。”
肺间质纤维化基金会首席医疗官Greg Cosgrove说：“患有进展型慢性纤维化ILD的患者可能有与其他呼吸系统疾病相似的症状，可能会延误对患者的准确诊断。”“nintedanib的新适应症为医生及其患者（如干燥综合症）提供了治疗选择，因为现在有一种治疗方案可以帮助减缓肺功能的下降。”
关于第三阶段INBUILD试验
INBUILD试验发表在New England Journal of Medicine上，是一项随机，双盲，安慰剂对照，平行组试验，在15个国家的153个地点进行，评估了Ofev的疗效和安全性（150 mg，对于具有进行性表型的慢性纤维化ILD患者，每日两次，超过52周。共评估了663名患者，其中412名（62.1%）在高分辨率CT（HRCT）上具有常见的间质性肺炎（UIP）样模式。患者的随机化基于通过HRCT检测的纤维化模式。通过用力肺活量（FVC）的年下降率评估肺功能，FVC是肺功能的既定测量值。
结果显示，相对于安慰剂，Ofev使一系列患者的肺功能丧失减慢了57%（107 mL/年）。在HRCT上具有UIP样纤维化模式的患者中，结果显示用Ofev与安慰剂治疗减缓了肺功能丧失61%（128.2mL/年）。
在该试验中，Ofev的安全性和耐受性特征与先前在IPF研究中所见的一致，最常见的不良反应是腹泻。
关于Ofev
Ofev已经在美国和75多个国家被批准用于治疗IPF患者。2019年9月，Ofev在美国被批准作为减缓SSc ILD患者肺功能下降速度的第一种也是唯一一种治疗方法。
Ofev患者支持
为了支持开处方药的人，Boehringer Ingelheim开发了OPEN DOORS®-一项全面的患者支持计划，提供广泛的护理，社会资源和财务支持服务。可通过www.ofev.com和1-866-673-6366访问，开放式服务和资源包括：
每周7天，每天24小时获得护士支持
社会资源服务，以确定当地资源，如支持团体和医生预约的交通
协助寻找财政资源以支持获得Ofev
获取有关IPF，SSc ILD和具有进行性表型的慢性纤维化ILD的教育信息
什么是OFEV？
OFEV是一种使用的处方药：
治疗患有称为特发性肺纤维化（IPF）的肺病的人，或治疗患有慢性（持久）间质性肺病的人，其中肺纤维化继续恶化（进展），或减缓系统性硬化相关间质性肺病（SSc-ILD）（也称为硬皮病相关ILD）患者肺功能下降的速度。目前尚不清楚OFEV对儿童是否安全有效。
重要的安全信息
我应该知道OFEV（nintedanib）最重要的信息是什么？
OFEV可能对未出生的婴儿造成伤害，出生缺陷或死亡。女性在服用OFEV时不应怀孕。能够怀孕的女性应在开始治疗前进行妊娠试验，并应在最后一次给药期间和至少3个月内使用高效节育措施。在此期间，与您的医生讨论哪种节育方法适合您。使用激素避孕药的妇女也应使用屏障避孕方法（如男性避孕套或杀精子剂）。如果您怀孕或认为您在服用EV时怀孕，请立即告诉您的医生。
在使用OFEV之前，我应该告诉我的医生什么？
在您服用OFEV之前，请告诉您的医生您的所有医疗状况，包括您是否有：肝脏问题、心脏问题、血栓病史、出血问题或出血问题的家族史、最近在你的胃（腹部）区域进行了手术。
如果你有以下情况，请告诉你的医生：
怀孕或计划怀孕。
母乳喂养或计划母乳喂养。目前尚不清楚OFEV是否会进入您的母乳。服用OFEV时不应该母乳喂养。
是吸烟者。您应该在服用OFEV之前戒烟，并在治疗期间避免吸烟。
告诉你的医生你服用的所有药物，包括处方药和非处方药，维生素和草药补充剂，如圣约翰草。
OFEV可能产生哪些副作用？
OFEV可能会引起严重的副作用,如果您有任何副作用，请立即告诉您的医生，包括：
肝脏问题。不明原因的症状可能包括皮肤变黄或眼睛白色部分（黄疸），深色或棕色（茶色）尿液，胃区（腹部）右上侧疼痛，出血或瘀伤比正常更容易，感到疲倦或食欲不振。在开始使用OFEV之前和治疗期间，您的医生将进行血液检查以检查您的肝脏工作状况。
腹泻，恶心和呕吐。您的医生可能会建议您饮用液体或服用药物来治疗这些副作用。告诉你的医生你是否有这些症状，如果它们没有消失或变得更糟，如果你正在服用非处方泻药，大便软化剂和其他药物或膳食补充剂。
心脏病发作。心脏病的症状可能包括胸痛或压力，手臂，背部，颈部或下颌疼痛，或呼吸短促。
中风的症状可能包括身体一侧的麻木或虚弱，说话困难，头痛或头晕。
出血问题。OFEV可能会增加出血问题的机会。告诉你的医生你是否有不寻常的出血，瘀伤，不愈合的伤口，和/或你是否服用血液稀释剂，包括处方血液稀释剂和非处方阿司匹林。
撕裂胃或肠壁（穿孔）。OFEV可能会增加您胃或肠壁撕裂的机会。告诉你的医生你的胃区是否有疼痛或肿胀。
OFEV最常见的副作用是腹泻，恶心，胃痛，呕吐，肝脏问题，食欲减退，头痛，体重减轻和高血压。
这些并不是OFEV的所有可能副作用。有关详细信息，请咨询您的医生或药剂师。我们鼓励您向FDA报告处方药的负面副作用。
以下为英文原稿：
Ridgefield, Conn., March 9, 2020 – Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first treatment for people with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. Unclassifiable ILDs, autoimmune ILDs, chronic hypersensitivity pneumonitis, sarcoidosis, myositis, sjogren’s syndrome, coal workers pneumoconiosis and idiopathic forms of interstitial pneumonias such as idiopathic non-specific interstitial pneumonia are among the diseases that may develop a progressive form of chronic fibrosing ILD.
Ofev, a multi-targeted tyrosine kinase inhibitor that inhibits key pathways involved in lung fibrosis in ILDs, is currently approved for idiopathic pulmonary fibrosis (IPF) and to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated ILD (SSc-ILD), two types of ILDs. Ofev received Breakthrough Therapy Designation from the U.S. FDA for chronic fibrosing ILDs with a progressive phenotype in October 2019. This new approval now makes Ofev available for patients with chronic fibrosing ILDs in which lung fibrosis continues to worsen.
The FDA approval is based on the INBUILD® trial, the first Phase III clinical trial in the field of ILDs to group patients based on the clinical behavior of their disease rather than the primary clinical diagnosis. In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies. The most common adverse reactions reported in greater than or equal to five percent in Ofev-treated patients compared to placebo were diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, weight decreased, headache, hypertension, nasopharygitis, upper respiratory tract infection, urinary tract infections, fatigue and back pain. Please see additional Important Safety Information included below.
“Chronic fibrosing ILDs with a progressive phenotype lead to respiratory symptoms and worsening lung function,” said Kevin Flaherty, M.D., professor of medicine, Division of Pulmonary and Critical Care Medicine, University of Michigan in Ann Arbor, Michigan, and lead investigator of the INBUILD trial. “This approval provides a therapeutic option for many patients who did not have an approved treatment until today.”
Interstitial lung diseases encompass more than 200 disorders, which are classified as rare diseases, that can lead to pulmonary fibrosis – an irreversible scarring of lung tissue that negatively impacts lung function. Chronic fibrosing ILDs in which lung fibrosis continues to worsen are estimated to occur in 18 to 32 percent of patients with ILDs.
“As a leader in the field of ILD research, we are fully committed to better understanding how to treat these devastating diseases,” said Thomas Seck, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. “Today’s approval marks a major advancement in ILD research and is an important milestone just six months after the approval of Ofev to slow the rate of decline in pulmonary function in patients with SSc-ILD.”
“Patients with a progressive form of chronic fibrosing ILDs may have symptoms that are similar to other respiratory illnesses and that may delay getting an accurate diagnosis for patients,” said Greg Cosgrove, M.D., chief medical officer, Pulmonary Fibrosis Foundation. “The new indication for nintedanib provides a therapeutic option for physicians and their patients as there is now a treatment option that can help slow the decline in lung function.”
About the Phase III INBUILD trial
The INBUILD trial, which was published in the New England Journal of Medicine, was a randomized, double-blind, placebo-controlled, parallel group trial conducted at 153 sites in 15 countries that evaluated the efficacy and safety of Ofev (150 mg, twice-daily) over 52 weeks in patients with chronic fibrosing ILDs with a progressive phenotype. A total of 663 patients were evaluated, of whom 412 (62.1 percent) had a usual interstitial pneumonia (UIP)-like pattern on high-resolution CT (HRCT). Randomization of patients was based on the fibrotic patterns as detected through HRCT. Lung function was assessed by the annual rate of decline in forced vital capacity (FVC), which is an established measurement of lung function.
Results showed that Ofev slowed the loss of pulmonary function by 57 percent (107 mL/year) across a range of patients relative to placebo. In patients with UIP-like fibrotic pattern on HRCT, results showed that treatment with Ofev-versus placebo slowed the loss of pulmonary function by 61 percent (128.2mL/year).
In this trial, the safety and tolerability profile of Ofev was consistent with what was previously seen in IPF studies, with the most common adverse reaction being diarrhea.
About Ofev
Ofev is already approved in the U.S. and more than 75 countries for the treatment of patients living with IPF. In September 2019, Ofev was approved in the U.S. as the first and only therapy to slow the rate of decline in pulmonary function in patients with SSc-ILD.
Ofev patient support
To support people who are prescribed Ofev, Boehringer Ingelheim has developed OPEN DOORS® – a comprehensive patient support program that provides a broad range of nursing, social resources, and financial support services. Accessible through www.ofev.com and at 1-866-673-6366, OPEN DOORS services and resources include:
Access to nurse support 24 hours a day, 7 days a week
Social resource services to identify local resources, such as support groups and transportation to doctor appointments
Assistance in finding financial resources to support access to Ofev
Access to educational information on IPF, SSc-ILD and chronic fibrosing ILDs with a progressive phenotype
What is OFEV?
OFEV is a prescription medicine used:
to treat people with a lung disease called idiopathic pulmonary fibrosis (IPF).
or
to treat people with a chronic (long lasting) interstitial lung disease in which lung fibrosis continues to worsen (progress).
or
to slow the rate of decline in lung function in people with systemic sclerosis-associated interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
It is not known if OFEV is safe and effective in children.
Important Safety Information
What is the most important information I should know about OFEV (nintedanib)?
OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant while taking OFEV. Women who are able to become pregnant should have a pregnancy test before starting treatment and should use highly effective birth control during and for at least 3 months after your last dose. Talk with your doctor about what birth control method is right for you during this time. Women using hormonal birth control should also use a barrier method of birth control (such as male condoms or spermicide). If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.
What should I tell my doctor before using OFEV?
Before you take OFEV, tell your doctor about all of your medical conditions, including if you have:
liver problems.
heart problems.
a history of blood clots.
a bleeding problem or a family history of a bleeding problem.
had recent surgery in your stomach (abdominal) area.
Tell your doctor if you:
are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your breast milk. You should not breastfeed while taking OFEV.
are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during treatment.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s wort.
What are the possible side effects of OFEV?
OFEV may cause serious side effects.
TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side effects, including:
Liver problems. Unexplained symptoms may include yellowing of your skin or the white part of your eyes (jaundice), dark or brown (tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood tests to check how well your liver is working before starting and during your treatment with OFEV.
Diarrhea, nausea, and vomiting. Your doctor may recommend that you drink fluids or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and other medicines or dietary supplements.
Heart attack. Symptoms of a heart problem may include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.
Stroke. Symptoms of a stroke may include numbness or weakness on one side of your body, trouble talking, headache, or dizziness.
Bleeding problems. OFEV may increase your chances of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do not heal, and/or if you are taking a blood thinner, including prescription blood thinners and over-the-counter aspirin.
Tear in your stomach or intestinal wall (perforation). OFEV may increase your chances of having a tear in your stomach or intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask your doctor or pharmacist. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.
Please see full Prescribing Information, including Patient Information.
CL-OF-100032 03.2020
About Boehringer Ingelheim Pharmaceuticals, Inc.
Boehringer Ingelheim Pharmaceuticals, Inc., based in Ridgefield, Conn., is the largest U.S. subsidiary of Boehringer Ingelheim Corporation.
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