Vanda宣布Bysanti™新药申请提交；FDA预计将于2026年初作出决定-动脉网

Vanda Announces Bysanti™ NDA Filing; FDA Decision Expected in Early 2026

CISION 等信源发布 2025-05-05 19:59

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WASHINGTON

华盛顿

，

May 5, 2025

2025年5月5日

/PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq:

/PRNewswire/ -- Vanda Pharmaceuticals Inc.（Vanda）（纳斯达克：

VNDA

越南语

) today announced that the U.S. Food and Drug Administration (FDA) informed Vanda that the New Drug Application (NDA) for Bysanti™ (milsaperidone) has been filed, and that at this time no potential review issues have been identified. The FDA has set

）今天宣布，美国食品药品监督管理局（FDA）通知万达，Bysanti™（米拉培酮）的新药申请（NDA）已被受理，且目前未发现潜在的审查问题。FDA已经设定

February 21, 2026

2026年2月21日

as the target date for decision on this application.

作为该申请决定的目标日期。

Bysanti™ is a new chemical entity, which was initially identified as an active metabolite of iloperidone. Vanda has discovered that milsaperidone, when administered orally, quickly interconverts to iloperidone. In clinical studies, milsaperidone and iloperidone have been shown to be bioequivalent at both low and high doses, administered both in single and multiple dose studies..

Bysanti™ 是一种新的化学实体，最初被确定为伊洛哌酮的活性代谢物。万达发现，口服米沙哌酮后，会迅速与伊洛哌酮相互转换。在临床研究中，米沙哌酮和伊洛哌酮在低剂量和高剂量下均显示出生物等效性，无论是在单剂量还是多剂量研究中。

The results of these clinical studies will be presented in late May, at the 2025 American Society of Clinical Psychopharmacology annual meeting in

这些临床研究的结果将于五月底，在2025年美国临床精神药理学学会年会上公布。

Scottsdale, Arizona

亚利桑那州斯科茨代尔

。

The efficacy and safety of Bysanti™ for the indications of bipolar I manic and mixed episodes and schizophrenia are supported by the clinical studies described on the iloperidone prescribing information. These include two studies in acute episodes of schizophrenia, one study in bipolar I disorder with manic or mixed episodes, and one relapse prevention study in schizophrenia.

Bysanti™ 对于治疗双相 I 型躁狂和混合发作以及精神分裂症的疗效和安全性，得到了 iloperidone 处方信息中描述的临床研究的支持。这些研究包括两项针对精神分裂症急性发作的研究、一项针对双相 I 型障碍伴有躁狂或混合发作的研究，以及一项针对精神分裂症复发预防的研究。

The safety of Bysanti™ is further supported by data in several thousand patients exposed to iloperidone in clinical studies, as well as the post marketing iloperidone experience, with more than 80,000 patient year exposures. The unique physical and chemical properties of milsaperidone make it amenable to the development of lipid esters that could allow the future development of long acting injectable formulations..

Bysanti™ 的安全性还得到了临床研究中数千名患者接触 iloperidone 的数据以及上市后超过 80,000 患者年的使用经验的支持。Milsaperidone 独特的物理和化学特性使其适合开发脂质酯，这可能有助于未来长效注射制剂的开发。

Bysanti™ is currently under development in a clinical study as a once-a-day adjunctive treatment of major depressive disorder (MDD) for patients with inadequate response on their current treatment. Results are expected in 2026.

Bysanti™ 目前正在一项临床研究中开发，作为重度抑郁症（MDD）患者当前治疗效果不佳时的每日一次辅助治疗。预计结果将在2026年公布。

Bysanti™ is eligible for 5 year regulatory data exclusivity if approved by the FDA. Current Bysanti™ related patent applications, if issued, would extend into the 2040's.

如果获得FDA批准，Bysanti™将有资格享受5年的监管数据独占期。当前与Bysanti™相关的专利申请若获授权，有效期将延续至2040年代。

Bysanti™ belongs to the class of atypical antipsychotics showing strong affinity to the alpha 1 adrenergic receptor, in addition to certain serotonin and dopamine receptors that are believed to explain its therapeutic effects.

Bysanti™ 属于非典型抗精神病药物，对α1肾上腺素受体以及某些血清素和多巴胺受体表现出强烈的亲和力，这些受体被认为可以解释其治疗效果。

'The extraordinary discovery of bioequivalence to iloperidone, of this novel chemical entity, allows for the efficient development of Bysanti™ and opens new opportunities to further explore additional therapeutic applications of this molecule,' said Dr.

“这种新型化学实体与伊洛哌酮的生物等效性的非凡发现，使得Bysanti™能够高效开发，并为探索该分子的更多治疗应用提供了新的机会，”博士说道。

Mihael Polymeropoulos

米哈伊尔·波利梅罗普洛斯

, Vanda's President, CEO and Chairman of the Board.

，万达的总裁、首席执行官兼董事会主席。

About Bysanti™

关于Bysanti™

Bysanti™ is a new chemical entity that belongs in the class of atypical antipsychotic drugs. If approved, Bysanti™ could be available for sale in the US in 2026. Bysanti™ is believed to achieve its therapeutic effect by interacting with a host of neurotransmitter receptors in the brain, including the alpha-adrenergic receptor, serotonin receptors and dopamine receptors.

Bysanti™ 是一种新的化学实体，属于非典型抗精神病药物类别。如果获得批准，Bysanti™ 可能会在2026年在美国上市销售。Bysanti™ 被认为通过与大脑中的多种神经递质受体相互作用来实现其治疗效果，这些受体包括α-肾上腺素受体、5-羟色胺受体和多巴胺受体。

Exclusivity, including pending patent applications, could extend into the 2040s..

包括待批的专利申请在内，独家权限可能延续至 2040 年代。

About Vanda Pharmaceuticals Inc.

关于万达制药公司

Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit

Vanda是一家领先的全球生物制药公司，专注于开发和商业化创新疗法，以满足未被满足的医疗需求并改善患者的生活。欲了解有关Vanda Pharmaceuticals Inc.的更多信息，请访问

www.vandapharma.com

and follow us on X @vandapharma.

关注我们在X平台上的账号 @vandapharma。

CAUTIONARY NOTE REGARDING FORWARD LOOKING STATEMENTS

关于前瞻性陈述的谨慎声明

Various statements in this press release, including, but not limited to, statements regarding the potential to develop long acting injectable formulations of Bysanti™, the expected timing of the clinical study results for Bysanti™ in MDD, Bysanti™'s mechanism of action, the potential commercial availability of Bysanti™, the potential to extend patent exclusivity for Bysanti™ into the 2040s, the potential to develop additional therapeutic applications for Bysanti™, and the anticipated timing of the completion of the FDA's review of the Bysanti™ NDA are 'forward-looking statements' under the securities laws.

本新闻稿中的各种声明，包括但不限于关于开发Bysanti™长效注射制剂的潜力、Bysanti™在重度抑郁症（MDD）中临床研究结果的预期时间、Bysanti™的作用机制、Bysanti™潜在的商业可用性、将Bysanti™专利独占期延长至2040年代的可能性、开发Bysanti™其他治疗应用的潜力，以及FDA完成对Bysanti™新药申请（NDA）审查的预期时间，均属于证券法规定的“前瞻性声明”。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to complete its clinical study in MDD and report results in 2026, Vanda's assumptions regarding how Bysanti™ achieves its therapeutic effect, Vanda's ability to obtain regulatory approval for Bysanti™ for the acute treatment of bipolar I disorder and schizophrenia and initiate its commercial launch in 2026, Vanda's ability to satisfy the conditions necessary to extend Bysanti™'s patent exclusivity into the 2040s, Vanda's ability to identify additional indications for Bysanti™ and the FDA's ability to complete its review of, and reach a decision with respect to, the Bysanti™ NDA by .

所有非历史事实的陈述均可能被视为前瞻性陈述。前瞻性陈述基于当前的预期和假设，这些预期和假设涉及风险、环境变化及不确定性。可能导致实际结果与Vanda公司前瞻性陈述中反映的结果存在重大差异的重要因素包括但不限于：Vanda完成其在重度抑郁症（MDD）领域的临床研究并在2026年报告结果的能力；Vanda关于Bysanti™如何实现其治疗效果的假设；Vanda获得Bysanti™用于急性治疗I型双相情感障碍和精神分裂症的监管批准并在2026年启动商业发布的能力；Vanda满足延长Bysanti™专利独占期至2040年代所需条件的能力；Vanda为Bysanti™识别其他适应症的能力；以及FDA完成对Bysanti™新药申请（NDA）的审评并作出决定的能力。

February 21, 2026

2026年2月21日

. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the 'Cautionary Note Regarding Forward-Looking Statements', 'Risk Factors' and 'Management's Discussion and Analysis of Financial Condition and Results of Operations' sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S.

因此，无法保证万达预期的结果或发展将会实现，或者即使基本实现，它们将对万达产生预期的后果或影响。本新闻稿中的前瞻性陈述应结合影响万达业务和市场的各种风险和不确定性一起评估，特别是万达最近的年度报告Form 10-K中“关于前瞻性陈述的警示声明”、“风险因素”和“管理层对财务状况及运营结果的讨论与分析”部分所确定的风险，以及万达随后提交的季度报告Form 10-Q、当前报告Form 8-K和其他提交给美国证券交易委员会的文件中更新的内容。

Securities and Exchange Commission, which are available at .

证券交易委员会，可从以下网址获取。

www.sec.gov

. All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf.

.所有以书面或口头形式发布的、可归因于Vanda或任何代表其行事的人的所有前瞻性声明，均以本文中包含或提及的警示性声明为准，这些声明在整体上被明确限定。Vanda提醒投资者不要过分依赖Vanda或代表其发布所做的前瞻性声明。

The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law..

本新闻稿中的信息仅提供至本新闻稿发布之日，Vanda 不承担任何更新或公开修订前瞻性声明的义务，并明确拒绝此类义务，无论是否因新信息、未来事件或其他原因，除非法律要求。

Corporate Contact:

公司联系人：

Kevin Moran

凯文·莫兰

Senior Vice President, Chief Financial Officer and Treasurer

高级副总裁、首席财务官兼司库

Vanda Pharmaceuticals Inc.

万达制药公司

202-734-3400

pr@vandapharma.com

Jim Golden