XYRA宣布已颁发第五项美国专利，该专利系列保护了Budiodarone在管理房颤方面的使用，直至2040年之后-动脉网

XYRA Announces the Issuance of a Fifth New US Patent in a Series of Patents Which Protect the Use of Budiodarone in the Management of Atrial Fibrillation till after 2040

CISION 等信源发布 2025-04-24 15:00



可切换为仅中文







Budiodarone shown in Phase 2 to reduce atrial fibrillation symptoms and long episodes of atrial fibrillation (LEAF)

Budiodarone在第二阶段显示出减少心房颤动症状和长时间心房颤动（LEAF）的效果

FDA gives guidance on steps necessary to gain approval and incorporate wearable AF monitoring devices into label for budiodarone

FDA就获得批准并将可穿戴AF监测设备纳入budioarone标签的必要步骤提供指导。

Five granted US patents align with FDA's guidance and protect the drug and label till after 2040

五项已获美国专利与FDA的指导方针一致，并保护药品和标签直至2040年之后。

LOS ALTOS, Calif.

加利福尼亚州洛斯阿尔托斯

，

April 24, 2025

2025年4月24日

/PRNewswire/ -- XYRA LLC, a private biopharmaceutical company, is committed to developing innovative therapies for cardiac rhythm disorders with high unmet need. With widespread use of FDA approved wearable Atrial Fibrillation (AF) monitoring devices in detecting as well as monitoring arrhythmias, it is now possible to identify subjects with long episodes of .

/PRNewswire/ -- XYRA有限责任公司，一家私人生物制药公司，致力于为具有高度未满足需求的心律失常开发创新疗法。随着FDA批准的可穿戴房颤（AF）监测设备在检测和监测心律失常方面的广泛使用，现在可以识别出有长时间发作的患者。

AF (LEAF)

AF（LEAF）

and symptoms who are at high risk of complications including stroke, heart failure and progression to permanent AF.

高危并发症患者，包括中风、心力衰竭以及进展为永久性房颤。

Having recently received FDA guidance on the approval pathway and a proposed label for budiodarone in the management of AF which will require monitoring with an FDA approved wearable device, the company is now pleased to announce the issuance of a series of new US patents that align with this guidance. The company (XYRA) now has 5 new patents that align with our proposed US label indications (Patent No.

近日，公司收到了美国食品药品监督管理局（FDA）关于 budiodarone 用于治疗心房颤动（AF）的审批路径指导以及拟定的药品标签，这将需要使用FDA批准的可穿戴设备进行监测。公司现在很高兴地宣布，已获得一系列与该指导一致的新美国专利。公司（XYRA）目前已拥有5项与我们拟定的美国标签适应症一致的新专利（专利号。

11,759,640) and directions for use (Patent No. 11,839,768) of budiodarone and allow a physician to identify and treat a patient with LEAF with the lowest most effective dose of the drug. Patent No. 12,115,373 instructs a physician treating a patient with non-permanent AF on how to switch a patient from an existing antiarrhythmic drug to an effective dose of budiodarone to eliminate LEAF.

11,759,640）和使用说明（专利号11,839,768）涉及布地奥达隆，帮助医生识别并以最低有效剂量治疗LEAF患者。专利号12,115,373指导医生如何将非永久性房颤患者从现有的抗心律失常药物转换为布地奥达隆的有效剂量，以消除LEAF。

The newest patent, Patent No. 12,257,228, instructs a physician how to cardiovert a patient with persistent AF to normal sinus rhythm with oral budiodarone, before treating them chronically to prevent recurrence..

最新专利，专利号12,257,228，指导医生如何使用口服布地酮将持续性房颤患者的心律转复为正常窦性心律，然后进行长期治疗以防止复发。

The fifth patent, (Patent No. 11,975,202) covers the use of budiodarone and monitoring with wearables to prevent progression of non-permanent to permanent AF. Progression of non-permanent to permanent AF occurs frequently and is associated with high risk of thrombo-embolic strokes, heart attacks, congestive heart failure and poor outcomes. Preventing such progression would have immense public health benefits for the up to 7 million US subjects with non-permanent AF who are destined to progress to permanent AF if left untreated.

第五项专利（专利号11,975,202）涵盖了使用布地达隆和通过可穿戴设备进行监测，以防止非永久性房颤进展为永久性房颤。非永久性房颤进展为永久性房颤的情况频繁发生，并且与高风险的血栓栓塞性中风、心脏病发作、充血性心力衰竭以及不良预后相关。预防这种进展将为多达700万未经治疗注定会从非永久性房颤发展为永久性房颤的美国患者带来巨大的公共卫生益处。

These 5 patents complement the previously issued patent (Patent No. 9,549,912) that uses a form of budiodarone to eliminate LEAF to create a safe harbor for stroke risk reduction and they extend coverage well past 2040..

这5项专利补充了之前发布的专利（专利号9,549,912），该专利使用一种budiodarone的形式消除LEAF，为减少中风风险创造了一个安全港，这些专利的保护期延长至2040年以后。

'We know the odds of having a stroke with AF goes up 5-fold in the 5 days after a LEAF greater than 5.5 hours. So now that we can identify subjects with these events with widely available wearable AF monitoring devices, it makes sense to treat them with budiodarone and monitor the response to therapy to prevent it happening again' said .

“我们知道，在LEAF超过5.5小时后的5天内，房颤（AF）患者中风的几率会增加5倍。因此，现在我们可以通过广泛可用的可穿戴房颤监测设备来识别这些事件的患者，使用Budiodarone进行治疗并监测治疗反应以防止再次发生是合理的。”

Peter Milner M.D

彼得·米尔纳医学博士

., FACC, managing member XYRA. He added. 'These 5 new patents direct intervention with the right dose of budiodarone at the most opportune point in their disease process to improve symptoms, eliminate LEAF and modify progression of the disease. This will reduce stroke and heart failure risk and potentially long-term delay, or prevent, progression to harmful permanent AF'..

., FACC，XYRA管理成员。他补充道：‘这5项新专利指导在疾病过程中最合适的时机以正确的剂量使用budiodarone进行干预，以改善症状、消除LEAF并改变疾病的进展。这将降低中风和心力衰竭的风险，并有可能长期延缓或预防进展为有害的永久性AF。’

About Budiodarone:

关于布多拉酮：

Budiodarone is a Phase 3 enabled potentially first-in-class mixed ion channel blocker with esterase metabolism and thus a significantly shorter half-life than amiodarone with no evidence of accumulation to date in human or animal studies. It has been shown to treat AF by controlling symptoms, eliminating LEAF, reducing AF burden, and maintaining normal sinus rhythm..

布迪奥达隆是一种处于第三阶段的潜在首创新型混合离子通道阻滞剂，具有酯酶代谢特性，因此其半衰期显著短于胺碘酮，并且迄今为止在人类或动物研究中未发现积累现象。它已被证明可通过控制症状、消除LEAF、减少房颤负担以及维持正常窦性心律来治疗房颤。

About Atrial Fibrillation:

关于心房颤动：

Atrial Fibrillation (AF) is the most common sustained arrhythmia in adults, with approximately 44 million individuals estimated to have AF worldwide. It is associated with thromboembolic risk, impairment in cardiac performance, and other morbidities. In addition to the patients with symptomatic AF, the diagnosis is often first detected after a stroke, the development of left ventricular dysfunction, or incidentally. The management of AF has evolved over time.

心房颤动 (AF) 是成人中最常见的心律失常，全球约有 4400 万人患有 AF。它与血栓栓塞风险、心脏功能受损及其他合并症相关。除了有症状的 AF 患者外，AF 的诊断常常在中风后、左心室功能障碍发展过程中或偶然情况下首次被发现。AF 的管理随着时间的推移不断发展。

Due to accumulating evidence of improved outcomes, previous management strategies that focused on simple ventricular rate control have evolved to present therapies that seek to restore and maintain sinus rhythm. AF may be treated with anti-arrhythmic drugs (AAD), electrophysiological ablation, or some combination of the two..

由于不断积累的证据表明预后改善，以往专注于简单心室率控制的管理策略已演变为目前寻求恢复并维持窦性心律的疗法。心房颤动 (AF) 可以通过抗心律失常药物 (AAD)、电生理消融或两者的某种组合进行治疗。

About XYRA LLC:

关于XYRA有限责任公司：

XYRA LLC, is a private biopharmaceutical company committed to developing innovative therapies for cardiac rhythm disorders with high unmet need. The company's goal is to make AF management comparable to that of other common cardiac conditions like hypertension and hypercholesterolemia in which, upward dose titration of effective drugs guided by simple widely available monitoring tools used to confirm compliance and response to therapy, have consistently improved outcomes..

XYRA有限责任公司是一家私营生物制药公司，致力于为心脏节律紊乱等高需求未满足的疾病开发创新疗法。该公司的目标是使房颤管理类似于其他常见的心脏病状况，如高血压和高胆固醇血症，通过使用简单且广泛可用的监测工具来指导有效药物的剂量递增，以确认治疗的依从性和反应，从而持续改善结果。

For information:

仅供参考：

www.xyra.us

Investor Relations Contact:

投资者关系联系人：

Press@xyra.us

按下@xyra.us

Logo -

标志 -

https://mma.prnewswire.com/media/2671906/Xyra_Logo.jpg

SOURCE XYRA