DUBLIN, March 1, 2024 /PRNewswire/ -- Mallinckrodt Pharmaceuticals plc, a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Mallinckrodt's supplemental New Drug Application (sNDA) for the Acthar® Gel (repository corticotropin injection) Single-Dose Pre-filled SelfJect™ Injector (herein referred to as 'SelfJect'), a new delivery device for Acthar Gel for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.2 SelfJect is intended to provide the appropriate subcutaneous dose of Acthar Gel, as prescribed by a healthcare professional, and is designed to help give patients control of their administration.1,3.

都柏林，2024年3月1日/PRNewswire/--全球专业制药公司Mallinckrodt Pharmaceuticals plc今天宣布，美国食品和药物管理局（FDA）已批准Mallinckrodt的补充新药申请（sNDA），用于Acthar®凝胶（储存库促肾上腺皮质激素注射液）单剂量预填充SelfJect™注射器（以下简称“SelfJect”），为患有一系列慢性和急性炎症和自身免疫疾病的适当患者提供了一种新的Acthar凝胶递送装置。SelfJect旨在提供适当的皮下剂量的Acthar凝胶，如医疗保健专业人员所述，旨在帮助患者控制其给药。

Acthar Gel is a naturally sourced complex mixture of adrenocorticotropic hormone analogs and other pituitary peptides.2 Acthar Gel is approved by the U.S. FDA for the treatment of several autoimmune disorders and medical conditions known to cause inflammation.2

Acthar凝胶是一种天然来源的促肾上腺皮质激素类似物和其他垂体肽的复杂混合物。2 Acthar凝胶经美国FDA批准用于治疗几种已知引起炎症的自身免疫性疾病和医疗状况。2

'We're excited to bring this innovation to U.S. patients with chronic and acute inflammatory and autoimmune conditions. This approval reflects Mallinckrodt's longstanding commitment to clinical research and therapeutic modernization efforts providing a new delivery device for patients, caregivers, and medical professionals managing these challenging conditions,' said Peter Richardson, MRCP (UK), Executive Vice President and Chief Scientific Officer.

“我们很高兴能将这项创新带给患有慢性和急性炎症和自身免疫疾病的美国患者。MRCP（英国）执行副总裁兼首席科学官彼得·理查德森（PeterRichardson）说，这一批准反映了马林克罗特（Mallinckrodt）对临床研究和治疗现代化努力的长期承诺，为管理这些具有挑战性的疾病的患者、护理人员和医疗专业人员提供了一种新的分娩装置。

With this approval, Acthar Gel is the first in its class of medications to offer a self-controlled, pre-filled delivery device for appropriate patients with a range of chronic and acute inflammatory and autoimmune conditions.1,2 SelfJect may allow patients to self-administer Acthar Gel with fewer steps, as prescribed by a healthcare professional.1 The delivery device is pre-filled with the prescribed dose of Acthar Gel in 40-unit or 80-unit versions,1 is designed to help patients with dexterity issues,4 and has additional safety features including a hidden needle to help protect patients against needlestick injury.3

有了这一批准，Acthar凝胶是同类药物中第一个为患有一系列慢性和急性炎症和自身免疫性疾病的适当患者提供自我控制，预填充递送装置的药物。1,2 SelfJect可能允许患者以较少的步骤自我管理Acthar凝胶，按照医疗保健专业人员的规定。1输送装置预先填充了40单位或80单位版本的规定剂量的Acthar凝胶，1旨在帮助患有灵活性问题的患者，4并具有额外的安全功能，包括隐藏的针头，以帮助保护患者免受针刺伤。3

Acthar Gel has an established efficacy and safety profile, as well as a long track record of clinical experience spanning more than 70 years.2 Acthar Gel has been prescribed by over 9,200 healthcare professionals and used by more than 43,500 patients.5

Acthar凝胶具有既定的疗效和安全性，以及跨越70多年的临床经验。2 Acthar凝胶已被9200多名医疗保健专业人员处方，并被43500多名患者使用。5

Mallinckrodt is committed to providing therapy for appropriate patients with difficult-to-treat conditions. Mallinckrodt offers a suite of services for eligible Acthar Gel patients including support with insurance coverage, commercial copay assistance, a patient assistance program, injection training services, and customized assistance by a nurse navigator.

Mallinckrodt致力于为难以治疗的适当患者提供治疗。Mallinckrodt为符合条件的Acthar凝胶患者提供一套服务，包括保险范围支持、商业支付援助、患者援助计划、注射培训服务以及护士导航员的定制援助。

Mallinckrodt also offers a team of field-based experts who provide education for healthcare professionals on the reimbursement process as well as tools available for patients. For more information about Mallinckrodt's programs and patient support please visit ActharHCP.com.

Mallinckrodt还提供了一个基于现场的专家团队，他们为医疗保健专业人员提供报销流程方面的教育以及可用于患者的工具。有关Mallinckrodt项目和患者支持的更多信息，请访问ActharHCP.com。

SelfJect is expected to launch in the U.S. in the second half of 2024. Acthar Gel will continue to be available as an injection with a vial and syringe.

SelfJect预计将于2024年下半年在美国推出。阿克萨凝胶将继续作为小瓶和注射器的注射剂提供。

INDICATIONS

适应症

Acthar Gel is indicated for:

Acthar凝胶适用于：

Inducing a diuresis or a remission of proteinuria in nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus

在没有特发性尿毒症或红斑狼疮引起的尿毒症的肾病综合征中诱导利尿或蛋白尿缓解

Monotherapy for the treatment of infantile spasms in infants and children under 2 years of age

单一疗法治疗婴幼儿痉挛

Treatment of acute exacerbations of multiple sclerosis in adults. Controlled clinical trials have shown Acthar to be effective in speeding the resolution of acute exacerbations of multiple sclerosis. However, there is no evidence that it affects the ultimate outcome or natural history of the disease.

成人多发性硬化症急性加重的治疗。对照临床试验表明，Acthar可有效加速多发性硬化症急性加重的消退。然而，没有证据表明它会影响疾病的最终结果或自然史。

Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa such as: keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroiditis, optic neuritis, chorioretinitis, anterior segment inflammation

涉及眼睛及其附件的严重急性和慢性过敏和炎症过程，例如：角膜炎，虹膜炎，虹膜睫状体炎，弥漫性后葡萄膜炎和脉络膜炎，视神经炎，脉络膜视网膜炎，前段炎症

Symptomatic sarcoidosis

症状性结节病

Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus

系统性红斑狼疮急性发作期间的治疗或维持治疗

Treatment during an exacerbation or as maintenance therapy in selected cases of dermatomyositis (polymyositis)

皮肌炎（多发性肌炎）急性发作期间的治疗或维持治疗

Adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy); ankylosing spondylitis

短期给药的辅助治疗（使患者度过急性发作或恶化）：银屑病关节炎；类风湿性关节炎，包括幼年类风湿性关节炎（部分病例可能需要低剂量维持治疗）；强直性脊柱炎

IMPORTANT SAFETY INFORMATION

重要安全信息

Contraindications

禁忌症

Acthar is contraindicated:

禁止表演：

For intravenous administration

静脉给药

In infants under 2 years of age who have suspected congenital infections

怀疑先天性感染的2岁以下婴儿

With concomitant administration of live or live attenuated vaccines in patients receiving immunosuppressive doses of Acthar

在接受免疫抑制剂量Acthar的患者中同时接种活疫苗或减毒活疫苗

In patients with scleroderma, osteoporosis, systemic fungal infections, ocular herpes simplex, recent surgery, history of the presence of a peptic ulcer, congestive heart failure, uncontrolled hypertension, primary adrenocortical insufficiency, adrenocortical hyperfunction, or sensitivity to proteins of porcine origin.

患有硬皮病，骨质疏松症，全身性真菌感染，眼部单纯疱疹，近期手术，消化性溃疡史，充血性心力衰竭，未控制的高血压，原发性肾上腺皮质功能不全，肾上腺皮质功能亢进或对猪源性蛋白质敏感的患者。

Warnings and Precautions

警告和注意事项

The adverse effects of Acthar are related primarily to its steroidogenic effects

Acthar的不良反应主要与其类固醇生成作用有关

Acthar may increase susceptibility to new infection or reactivation of latent infections

Acthar可能会增加对新感染的易感性或潜伏感染的重新激活

Suppression of the hypothalamic-pituitary-adrenal (HPA) axis may occur following prolonged therapy with the potential for adrenal insufficiency after withdrawal of the medication. Adrenal insufficiency may be minimized by tapering of the dose when discontinuing treatment. During recovery of the adrenal gland patients should be protected from the stress (e.g., trauma or surgery) by the use of corticosteroids.

长期治疗后可能会抑制下丘脑-垂体-肾上腺（HPA）轴，停药后可能会出现肾上腺功能不全。停止治疗时，可以通过逐渐减少剂量将肾上腺功能不全降至最低。在肾上腺恢复期间，应通过使用皮质类固醇保护患者免受压力（例如创伤或手术）。

Monitor patients for effects of HPA axis suppression after stopping treatment.

停止治疗后监测患者HPA轴抑制的效果。

Cushing's syndrome may occur during therapy but generally resolves after therapy is stopped. Monitor patients for signs and symptoms

库欣综合征可能在治疗期间发生，但通常在停止治疗后消退。监测患者的体征和症状

Acthar can cause elevation of blood pressure, salt and water retention, and hypokalemia. Monitor blood pressure and sodium and potassium levels

阿克萨可引起血压升高、盐和水潴留以及低钾血症。监测血压和钠钾水平

Acthar often acts by masking symptoms of other diseases/disorders. Monitor patients carefully during and for a period following discontinuation of therapy

Acthar通常通过掩盖其他疾病/紊乱的症状来起作用。在停止治疗期间和停止治疗后的一段时间内仔细监测患者

Acthar can cause gastrointestinal (GI) bleeding and gastric ulcer. There is also an increased risk for perforation in patients with certain GI disorders. Monitor for signs of perforation and bleeding

Acthar可引起胃肠道（GI）出血和胃溃疡。某些胃肠道疾病患者的穿孔风险也增加。监测穿孔和出血的迹象

Acthar may be associated with central nervous system effects ranging from euphoria, insomnia, irritability, mood swings, personality changes, and severe depression to psychosis. Existing conditions may be aggravated

Acthar可能与中枢神经系统影响有关，从欣快，失眠，易怒，情绪波动，性格改变，严重抑郁症到精神病。现有条件可能会加剧

Patients with comorbid disease may have that disease worsened. Caution should be used when prescribing Acthar in patients with diabetes and myasthenia gravis

患有合并症的患者可能会使疾病恶化。糖尿病和重症肌无力患者服用Acthar时应谨慎

Prolonged use of Acthar may produce cataracts, glaucoma, and secondary ocular infections. Monitor for signs and symptoms

长期使用Acthar可能会产生白内障，青光眼和继发性眼部感染。监测体征和症状

Acthar is immunogenic and prolonged administration of Acthar may increase the risk of hypersensitivity reactions. Cases of anaphylaxis have been reported in the postmarketing setting. Neutralizing antibodies with chronic administration may lead to loss of endogenous ACTH and Acthar activity

Acthar具有免疫原性，长时间服用Acthar可能会增加过敏反应的风险。上市后已报告过敏反应病例。长期服用中和抗体可能导致内源性ACTH和Acthar活性的丧失

There may be an enhanced effect in patients with hypothyroidism and in those with cirrhosis of the liver

甲状腺功能减退症患者和肝硬化患者的疗效可能增强

Long-term use may have negative effects on growth and physical development in children. Monitor pediatric patients

长期使用可能会对儿童的生长和身体发育产生负面影响。监测儿科患者

Decrease in bone density may occur. Bone density should be monitored in patients on long-term therapy

骨密度可能会降低。应监测长期治疗患者的骨密度

Adverse Reactions

不良反应

Commonly reported postmarketing adverse reactions for Acthar include injection site reaction, asthenic conditions (including fatigue, malaise, asthenia, and lethargy), fluid retention (including peripheral swelling), insomnia, headache, and blood glucose increased

Acthar上市后常见的不良反应包括注射部位反应、虚弱（包括疲劳、不适、虚弱和嗜睡）、液体潴留（包括外周肿胀）、失眠、头痛和血糖升高

The most common adverse reactions for the treatment of infantile spasms (IS) are increased risk of infections, convulsions, hypertension, irritability, and pyrexia. Some patients with IS progress to other forms of seizures; IS sometimes masks theses seizures, which may become visible once the clinical spasms from IS resolve.

治疗婴儿痉挛（IS）最常见的不良反应是感染，抽搐，高血压，易怒和发热的风险增加。一些IS患者进展为其他形式的癫痫发作；IS有时会掩盖这些癫痫发作，一旦IS的临床痉挛消退，癫痫发作可能就会变得可见。

Pregnancy

怀孕

Acthar may cause fetal harm when administered to a pregnant woman

阿克萨给孕妇服用时可能会对胎儿造成伤害

ABOUT MALLINCKRODT

关于MALLINCKRODT

Mallinckrodt is a global business consisting of multiple wholly owned subsidiaries that develop, manufacture, market and distribute specialty pharmaceutical products and therapies. The company's Specialty Brands reportable segment's areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, hepatology, nephrology, pulmonology, ophthalmology, and oncology; immunotherapy and neonatal respiratory critical care therapies; analgesics; and gastrointestinal products.

Mallinckrodt是一家全球性企业，由多个全资子公司组成，这些子公司开发、制造、营销和分销专业药品和疗法。该公司的专业品牌可报告分部的重点领域包括神经病学、风湿病学、肝病学、肾病学、肺病学、眼科和肿瘤学等专业领域的自身免疫性疾病和罕见疾病；免疫疗法和新生儿呼吸重症监护疗法；镇痛药；和胃肠道产品。

Its Specialty Generics reportable segment includes specialty generic drugs and active pharmaceutical ingredients.

其特殊仿制药可报告部分包括特殊仿制药和活性药物成分。