Viatris宣布推出Breyna™(布地奈德和Formoterol延胡索酸酯二水合物)吸入气溶胶,美国fda批准的首个通用版本的Symbicort®哮喘和慢性阻塞性肺疾病患者,与Kindeva合作

匹兹堡和伍德伯里,明尼苏达州。7月31日,2023 / 3提单/ -Viatris公司。全球医疗保健公司(纳斯达克:录像机),和Kindeva药物输送石油醚今天宣布推出Breyna™(布地奈德和formoterol延胡索酸酯二水合物)吸入气溶胶,第一个通用版的阿斯利康Symbicort^®简化新药申请(安达)通过美国食品和药物管理局(FDA)。Breyna, drug-device组合产品,表示对某些患者哮喘或慢性阻塞性肺疾病(COPD)并将立即在80毫克/ 4.5微克和160毫克/ 4.5微克剂量的优势。

Viatris北美穆Cotarelo负责人说:“我们是兴奋让Breyna美国市场的许多美国人患有哮喘和慢性阻塞性肺病。这次发射是多年的努力工作打破壁垒来访问和建立于我们过去的成功带来其他复杂产品市场我们继续价值链。成为第一个将fda批准的通用版本的Symbicort病人的访问是一个真实的例子是我们的使命的基石使全世界的人过上更健康在生命的每个阶段。”

Breyna的迹象包括哮喘患者中6岁及以上,和气流阻塞的维持治疗和减少在COPD患者急性加重,包括慢性支气管炎或肺气肿。Breyna并不表明急性支气管痉挛的缓解。160毫克/ 4.5微克表示治疗慢性阻塞性肺病的唯一力量。慢性阻塞性肺病是一个术语,用来描述一种慢性肺部疾病,特征是呼吸困难;它影响了超过1600万的美国人。哮喘导致呼吸困难而导致的气道肿胀,和大约2500万美国人有慢性疾病。

弥尔顿波伊尔,Kindeva药物输送的CEO,补充道:“启动Breyna代表一个重要的里程碑,因为它是第一个Symbicort在美国的fda批准的通用版本规定,其中最复杂drug-device组合产品治疗哮喘和慢性阻塞性肺病。我们很高兴Viatris以及许多Kindeva利用我们的同事都在不知疲倦地工作复杂药物传输技术这一重要呼吸道产品——支持持续的需要继续带来更多优质药品哮喘和慢性阻塞性肺病患者。”

为了进一步扩大Breyna, Viatris建立了钱项目提供合格commercially-insured患者,这可能有助于减少处方付现费用20美元每30天的供应。程序提供每月30美元或每年高达360美元每年12续加。该项目将在8月。

关于Breyna
Breyna表示治疗哮喘的患者6年及以上不充分控制长期控制哮喘的药物比如吸入激素(ICS)或治疗疾病权证起始的ICS和长效beta2-adrenergic受体激动剂(腊八粥)。Breyna 160毫克/ 4.5微克剂量表示气流阻塞的维持治疗慢性阻塞性肺病(COPD)患者,包括慢性支气管炎或肺气肿,Breyna 160毫克/ 4.5微克还表示,以减少慢性阻塞性肺病加重病人的。Breyna并不表明急性支气管痉挛的缓解。

重要的安全信息
Breyna禁忌在积状态或其他的主要治疗哮喘或慢性阻塞性肺病急性发作,强化措施是必需的,和在Breyna过敏症的任何成分。使用长效beta2-adrenergic受体激动剂(腊八粥)作为单一疗法(没有吸入激素(ICS))对哮喘与与哮喘有关的死亡的风险增加相关。可用clinial控制试验的数据还表明,使用腊八作为单一疗法与哮喘有关的风险增加儿童和青少年患者的住院治疗。这些发现被认为是一个类腊八粥的效果。腊八粥时用于固定剂量结合ICS,大型临床试验的数据没有显示显著增加的风险严重与哮喘有关的事件(住院、插管、死亡),而独自ICS。Breyna不是救援药物和治疗急性症状不能代替快速吸入器。Breyna不应该开始在迅速恶化的病人的哮喘和慢性阻塞性肺病。患者接受Breyna不应该使用额外formoterol或其他腊八任何理由。局部感染白色念珠菌的口腔和咽Breyna患者中发生。病人应该Breyna吸入后冲洗口腔。 Lower respiratory tract infections, including pneumonia, have been reported following the administration of ICS. Due to possible immunosuppression, potential worsening of infections could occur. A more serious or even fatal course of chickenpox or measles can occur in susceptible patients. It is possible that systemic corticosteroid effects such as hypercorticism and adrenal suppression may occur, particularly at higher doses. Particular care is needed for patients who are transferred from systemically active corticosteroids to ICS. Deaths due to adrenal insufficiency have occurred in asthmatic patients during and after transfer from systemic corticosteroids to less systemically available ICS. Caution should be exercised when considering administration of Breyna in patients on long-term ketoconazole and other known potent CYP3A4 inhibitors. As with other inhaled medications, paradoxical bronchospasm may occur with Breyna. Immediate hypersensitivity reactions may occur, as demonstrated by cases of urticaria, angioedema, rash, and bronchospasm. Excessive beta-adrenergic stimulation has been associated with central nervous system and cardiovascular effects. Breyna should be used with caution in patients with cardiovascular disorders especially coronary insufficiency, cardiac arrhythmias, and hypertension. Long-term use of ICS may result in a decrease in bone mineral density (BMD Assessment of BMD is recommended prior to initiating Breyna and periodically thereafter. ICS may result in a reduction in growth velocity when administered to pediatric patients. Glaucoma, increased intracolular pressure, and cataracts have been reported following the administration of ICS, including budesonide, a component of Breyna. Close monitoring for glaucoma and cataracts is warranted in patients with a change in vision or history of increased intraocular pressure. In rare cases, patients on ICS may present with systemic eosinophilic conditions. Breyna should be used with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, ketoacidosis, and in patients who are unusually responsive to sympathomimetic amines. The most common adverse reactions ≥3% reported in asthma clinical trials included nasopharyngitis, headache, upper respiratory tract infection, pharyngolaryngeal pain, sinusitis, influenza, back pain, nasal congestion, stomach discomfort, vomiting, and oral candidiasis. The most common adverse reactions ≥3% reported in COPD clinical trials included nasopharyngitis, oral candidiasis, bronchitis, sinusitis, and upper respiratory tract infection. Breyna should be administered with caution to patients being treated with MAO inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents. Beta-blockers may not only block the pulmonary effect of beta-agonists, such as formoterol, but may produce severe bronchospasm in patients with asthma. ECG changes and/or hypokalemia associated with nonpotassium-sparing diuretics may worsen with concomitant beta-agonists. Use caution with the coadministration of Breyna.

关于Viatris
Viatris公司(纳斯达克:录像机)是一个全球性的医疗保健公司全球让人生活更健康在生命的每个阶段。我们提供的药品,推进可持续运营,开发创新的解决方案和利用我们的集体专长,连接更多的人更多的产品和服务通过我们独一无二的全球医疗网关188bet上不了^®。成立于2020年11月,Viatris汇集了科学、制造和分销专业知识与证明监管、医疗和商业功能交付高质量的药物给病人在165多个国家和地区。Viatris”投资组合包含超过1400个批准分子跨广泛的治疗领域,生成非传染性和传染性疾病,包括全球公认的品牌,复杂的泛型和品牌药物,和各种非处方药消费产品。全球有超过38000的同事,Viatris总部设在美国在匹兹堡,与全球中心、上海和海得拉巴,印度。学习更多在viatris.com和investor.viatris.com在Twitter上,联系我们@ViatrisInc,LinkedIn和YouTube。

关于Kindeva药物输送
Kindeva药是一个全球性的合同开发生产组织关注drug-device组合产品。Kindeva药研发和制造产品在广泛的复杂的药物传输格式,包括注射剂(自我注射器、皮内注射、微针),肺和鼻,皮肤补丁。其服务提供跨越早期药物产品fill-finish可行性通过商业规模,容器关闭系统制造、drug-device产品组装。Kindeva药服务全球客户基础的九个制造和研发设施位于美国和英国的更多信息,请访问www.kindevadd.com。

前瞻性陈述
这个新闻稿包含语句构成“前瞻性陈述”。These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements that the launch of Breyna demonstrates the companies' commitment to bringing complex generic medicines to the market to help increase patient access; Breyna will be immediately available in both 80 mcg/4.5 mcg and 160 mcg/4.5 mcg dosage strengths; this launch represents years of hard work breaking down barriers to access and builds upon our past successes of bringing other complex products to market as we continue to move up the value chain; to further expand access to Breyna, Viatris has established a copay program offered for eligible commercially-insured patients, which may help reduce out-of-pocket expenses on prescriptions to as little as $20 per 30-day supply; and, the program will be available in August. Factors that could cause or contribute to such differences include, but are not limited to: the possibility that the Company may be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility that the Company may be unable to achieve expected benefits, synergies and operating efficiencies in connection with acquisitions, divestitures, or its global restructuring program, within the expected timeframe or at all; impairment charges or other losses related to the divestiture or sale of businesses or assets; the Company's failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics, including the ongoing challenges and uncertainties posed by COVID-19; actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market, including but not limited to "at-risk" launches; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described in Viatris' filings with the Securities and Exchange Commission (SEC). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this release other than as required by law.

源Viatris公司。

为进一步的信息:媒体:+ 1.724.514.1968,Communications@viatris.com;投资者:+ 1.412.707.2866 InvestorRelations@viatris.com;詹妮弗·莫尔,Jennifer.Mauer@viatris.com;比尔Szablewski, William.Szablewski@viatris.com;马特·克莱恩,Matthew.Klein@viatris.com;Kindeva联系:克里斯巴尔,Kris.barr@kindevadd.com