BRENZAVVY will be priced at $47.75 a month and eliminates hassles associated with insurance benefit design

Brenzavvvy将每月定价47.75美元，消除了与保险福利设计相关的麻烦

Marlborough, MA – December 18, 2023 – TheracosBio today announced that BRENZAVVY® (bexagliflozin), an oral sodium-glucose cotransporter 2 (SGLT2) inhibitor approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, is now available by prescription through DiRx, an online mail order pharmacy licensed to fill and ship prescriptions to all 50 states and the District of Columbia..

马萨诸塞州马尔堡–2023年12月18日–TheracosBio今天宣布，Brenzavvvy®（bexagliflozin）是一种口服钠-葡萄糖协同转运蛋白2（SGLT2）抑制剂，已被FDA批准作为饮食和运动的辅助手段，以改善2型糖尿病成年人的血糖控制，现已通过DiRx处方提供，一家在线邮购药店，获得许可，可以向所有50个州和哥伦比亚特区填写和运送处方。。

BRENZAVVY will cost only $47.75 a month, and the prescription will not be processed via insurance companies. That means, in addition to being more affordable for the uninsured, insured patients and physicians will not need to jump through onerous hoops, such as prior authorization or step therapy, to fill the prescription..

BRENZAVVY每月只需47.75美元，而且处方不会通过保险公司处理。这意味着，除了为未参保的患者提供更实惠的服务外，参保患者和医生不需要通过事先授权或分步治疗等繁重的工作来完成处方。。

“TheracosBio is committed to helping patients with type 2 diabetes who could benefit from starting and staying on an SGLT2 inhibitor but cannot afford one,” said Brian Connelly, President and CEO of TheracosBio. “DiRx shares our vision to make affordable medications accessible to many more Americans irrespective of their insurance status.

TheracosBio总裁兼首席执行官布莱恩·康奈利（BrianConnelly）表示：“TheracosBio致力于帮助2型糖尿病患者，这些患者可以从开始和持续服用SGLT2抑制剂中受益，但负担不起。”。“迪克斯同意我们的愿景，即让更多的美国人无论其保险状况如何，都能获得负担得起的药物。

By partnering with DiRx, we can increase the accessibility of BRENZAVVY as the first affordably priced, once-daily SGLT2 inhibitor for patients.”.

通过与DiRx合作，我们可以增加BRENZAVVY的可及性，作为患者第一个价格合理，每日一次的SGLT2抑制剂。”。

Approximately 1 in 10 people in the United States have type 2 diabetes, but many patients report suboptimal adherence to medication due to high costs.  A study in Diabetes Care found that, among those with type 2 diabetes under the age of 65, 13.5% reported skipping doses, 13.9% took less medication, and 16.4% delayed filling a prescription to save money..

在美国，大约十分之一的人患有2型糖尿病，但许多患者报告说，由于费用高昂，对药物的依从性欠佳。糖尿病护理的一项研究发现，在65岁以下的2型糖尿病患者中，有13.5%的人报告跳过剂量，13.9%的人服用较少的药物，16.4%的人为了省钱而延迟开处方。。

“DiRx’s ‘Medicine For All’ motto was a key driver in creating the first national mail order pharmacy to introduce a direct sourcing model by skipping the supply chain middlemen and making more than 1,000 prescription generic medications very affordable and accessible to American consumers,” said Satish Srinivasan, Founder and CEO of DiRx.

DiRx创始人兼首席执行官萨蒂什·斯里尼瓦桑（SatishSrinivasan）表示：“DiRx的‘全民用药’座右铭是创建第一家国家邮购药房的关键驱动因素，该药房通过跳过供应链中间商，引入了直接采购模式，使1000多种处方仿制药成为美国消费者非常实惠和容易获得的药物。”。

“We’ve recently also started launching select branded medications to treat critical therapy needs at affordable cash prices without the need for insurance.  In this context, TheracosBio’s mission of ‘making diabetes therapy available for less than $50 per month without insurance’ was a great fit and we are proud to partner with them to launch BRENZAVVY among our portfolio of affordable diabetes therapies.”  .

“我们最近还开始推出精选品牌药物，以负担得起的现金价格治疗关键治疗需求，而无需保险。在这种情况下，TheracosBio的使命“使糖尿病治疗每月不到50美元，无需保险”非常适合，我们很荣幸与他们合作，推出Brenzavvvy，成为我们负担得起的投资组合之一糖尿病治疗。”。

BRENZAVVY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. BRENZAVVY is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents.

Brenzavvvy被认为是饮食和运动的辅助手段，可改善2型糖尿病成年人的血糖控制。不建议使用Brenzavvvy来改善1型糖尿病患者的血糖控制。3期临床研究表明，Brenzavvvy在24周后显着降低血红蛋白A1c和空腹血糖，无论是作为单一疗法，与二甲双胍联合使用，还是作为由多种方案组成的标准护理治疗的补充，包括二甲双胍，磺脲类，胰岛素，DPP4抑制剂或这些药物的组合。

Although BRENZAVVY is not approved for weight or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program..

尽管Brenzavvvy未被批准用于减肥或降压，但在临床计划中观察到体重和血压均适度下降。。

BRENZAVVY is available as 20 mg oral tablets recommended to be taken once daily, in the morning with or without food. BRENZAVVY is contraindicated in patients who are hypersensitive to bexagliflozin or any other ingredient in the BRENZAVVY tablet. The most common side effects of taking BRENZAVVY include female genital mycotic infections, urinary tract infections, and changes in urination, but more serious side effects are possible (see below, Important Safety Information about BRENZAVVY)..

Brenzavvvy有20毫克口服片剂，建议每天服用一次，早上有或没有食物。BRENZAVVY禁用于对贝沙格列嗪或BRENZAVVY片剂中任何其他成分过敏的患者。服用BRENZAVVY最常见的副作用包括女性生殖器真菌感染，尿路感染和排尿改变，但可能会产生更严重的副作用（见下文，有关BRENZAVVY的重要安全信息）。。

BRENZAVVY treatment can be initiated in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) greater than or equal to 30 mL/min/1.73 m2. Patients with eGFR between 30 and 59 mL/min/1.73 m2 are said to be in stage 3 chronic kidney disease. BRENZAVVY was the first SGLT2 inhibitor shown in a randomized, controlled clinical trial to be effective for glycemic control in adults with type 2 diabetes and stage 3 (3a + 3b) chronic kidney disease. .

Brenzavvvy治疗可以在2型糖尿病患者中开始，估计肾小球滤过率（eGFR）大于或等于30 mL/min/1.73 m2。据说eGFR在30至59 mL/min/1.73 m2之间的患者处于3期慢性肾脏疾病。Brenzavvvy是第一个在随机对照临床试验中显示的SGLT2抑制剂，可有效控制2型糖尿病和3期（3a+3b）慢性肾脏疾病成人的血糖。。。

To learn more about BRENZAVVY and for full prescribing information visit https://www.brenzavvy.com. To report suspected adverse reactions, contact TheracosBio at 1-855-BRENZAVVY (1-855-273-6928) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要了解有关BRENZAVVY的更多信息以及完整的处方信息，请访问https://www.brenzavvy.com.要报告疑似不良反应，请联系TheracosBio（电话1-855-Brenzavvvy（1-855-273-6928））或FDA（电话1-800-FDA-1088）或www.FDA.gov/medwatch。

Important Safety Information about BRENZAVVY

关于BRENZAVVY的重要安全信息

Limitation of Use: BRENZAVVY (bexagliflozin) is not recommended for use to improve glycemic control in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients.

使用限制：不建议使用Brenzavvvy（bexagliflozin）来改善1型糖尿病患者的血糖控制。它可能会增加这些患者患糖尿病酮症酸中毒的风险。

Contraindications

禁忌症

BRENZAVVY is contraindicated in patients with hypersensitivity to bexagliflozin or any excipient in BRENZAVVY. Anaphylaxis and angioedema have been reported with sodium-glucose co-transporter 2 (SGLT2) inhibitors.

BRENZAVVY对贝沙格列嗪或任何赋形剂过敏的患者禁用。钠-葡萄糖共转运蛋白2（SGLT2）抑制剂已报道过敏反应和血管性水肿。

Warnings and Precautions

警告和注意事项

Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis

1型糖尿病和其他酮症酸中毒患者的糖尿病酮症酸中毒

BRENZAVVY increases the risk of life-threatening ketoacidosis in patients with type 1 diabetes. Type 2 diabetes and pancreatic disorders are also risk factors for ketoacidosis and fatal events of ketoacidosis have been reported in patients with type 2 diabetes using SGLT2 inhibitors. Precipitating conditions for diabetic ketoacidosis or other ketoacidosis include under-insulinization due to insulin dose reduction or missed insulin doses, acute febrile illness, reduced caloric intake, ketogenic diet, surgery, volume depletion, and alcohol abuse.

Brenzavvvy增加了1型糖尿病患者危及生命的酮症酸中毒的风险。2型糖尿病和胰腺疾病也是酮症酸中毒的危险因素，据报道，使用SGLT2抑制剂的2型糖尿病患者发生酮症酸中毒致命事件。糖尿病酮症酸中毒或其他酮症酸中毒的诱发条件包括由于胰岛素剂量减少或胰岛素剂量错过而导致的胰岛素不足，急性发热性疾病，热量摄入减少，生酮饮食，手术，体积消耗和酒精滥用。

Signs and symptoms of diabetic ketoacidosis are consistent with dehydration and severe metabolic acidosis and include nausea, vomiting, abdominal pain, generalized malaise, and shortness of breath. Assess patients who present with signs and symptoms of metabolic ketoacidosis, regardless of blood glucose levels.

糖尿病酮症酸中毒的体征和症状与脱水和严重代谢性酸中毒一致，包括恶心，呕吐，腹痛，全身不适和呼吸急促。评估出现代谢性酮症酸中毒体征和症状的患者，无论血糖水平如何。

If suspected, discontinue BRENZAVVY, treat promptly and monitor for resolution before restarting. Consider ketone monitoring in patients with type 1 diabetes mellitus as well as in others at risk for ketoacidosis. Withhold BRENZAVVY in clinical situations known to predispose to ketoacidosis and resume when clinically stable.

如果怀疑，停止服用Brenzavvvy，立即治疗并在重新开始之前监测解决方案。考虑对1型糖尿病患者以及其他有酮症酸中毒风险的患者进行酮监测。在已知易患酮症酸中毒的临床情况下保留Brenzavvvy，并在临床稳定时恢复。

Educate all patients on the signs and symptoms of ketoacidosis and instruct patients to discontinue BRENZAVVY and seek medical attention immediately if signs and symptoms occur..

教育所有患者酮症酸中毒的体征和症状，并指示患者停止服用Brenzavvvy，如果出现体征和症状，立即就医。。

Lower Limb Amputation

下肢截肢术

Lower limb amputations have been observed in patients treated with BRENZAVVY in a study of patients with type 2 diabetes who had either established cardiovascular disease (CVD) or were at risk for CVD. Of the 23 BRENZAVVY-treated patients who had amputations, 15 were amputations of the toe and midfoot and 8 were amputations above and below the knee.

在一项针对患有心血管疾病（CVD）或有CVD风险的2型糖尿病患者的研究中，使用Brenzavvvy治疗的患者观察到下肢截肢。在接受Brenzavvvy治疗的23名截肢患者中，15名是脚趾和中足截肢，8名是膝盖以上和以下截肢。

Some patients had multiple amputations. Lower limb infections, gangrene, ischemia, and osteomyelitis were the most common precipitating medical events leading to the need for an amputation. The risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy..

一些患者多次截肢。下肢感染、坏疽、缺血和骨髓炎是最常见的导致截肢的医疗事件。既往有截肢史、外周血管疾病和神经病变的患者截肢风险最高。。

Before initiating BRENZAVVY, consider factors in the patient’s history that may predispose to the need for amputations, such as a history of prior amputation, peripheral vascular disease, neuropathy, and diabetic foot ulcers. Counsel patients receiving BRENZAVVY about the importance of routine preventative foot care and monitor for signs and symptoms of diabetic foot infection (including osteomyelitis), new pain or tenderness, sores or ulcers involving the lower limbs, and institute appropriate treatment..

在开始BRENZAVVY之前，考虑患者病史中可能导致截肢的因素，例如先前截肢史，周围血管疾病，神经病和糖尿病足溃疡。为接受Brenzavvvy治疗的患者提供常规预防性足部护理的重要性咨询，并监测糖尿病足感染（包括骨髓炎）的体征和症状，新的疼痛或压痛，涉及下肢的溃疡或溃疡，并进行适当的治疗。。

Volume Depletion

体积损耗

BRENZAVVY can cause intravascular volume contraction which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. Acute kidney injury requiring hospitalization and dialysis has been reported in patients with type 2 diabetes receiving SGLT2 inhibitors. Before initiating, assess volume status and renal function in patients with impaired renal function (eGFR less than 60 mL/min/1.73 m2), elderly patients, patients with low systolic blood pressure, or patients on loop diuretics.

Brenzavvvy可引起血管内容量收缩，有时可能表现为症状性低血压或肌酐的急性短暂变化。据报道，接受SGLT2抑制剂的2型糖尿病患者需要住院和透析的急性肾损伤。在开始之前，评估肾功能受损患者（eGFR小于60 mL/min/1.73 m2），老年患者，收缩压低的患者或服用袢利尿剂的患者的体积状态和肾功能。

In patients with volume depletion, correct this condition. After initiating, monitor for signs and symptoms of volume depletion and renal function..

对于容量耗尽的患者，请纠正这种情况。开始后，监测容量消耗和肾功能的体征和症状。。

Urosepsis and Pyelonephritis

尿脓毒症和肾盂肾炎

Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been identified in patients receiving SGLT2 inhibitors, including BRENZAVVY. Treatment with BRENZAVVY increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat them promptly..

在接受SGLT2抑制剂（包括BRENZAVVY）的患者中，已发现严重的尿路感染，包括需要住院治疗的尿脓毒症和肾盂肾炎。用BRENZAVVY治疗会增加尿路感染的风险。评估患者尿路感染的体征和症状，并及时治疗。。

Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues

与胰岛素和胰岛素促分泌剂同时使用的低血糖症

Insulin and insulin secretagogues (e.g., sulfonylureas) are known to cause hypoglycemia. BRENZAVVY may increase the risk of hypoglycemia when used in combination with insulin and/or an insulin secretagogue. A lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with BRENZAVVY..

已知胰岛素和胰岛素促分泌剂（例如磺脲类）会引起低血糖。当与胰岛素和/或胰岛素促分泌剂联合使用时，Brenzavvvy可能会增加低血糖的风险。与BRENZAVVY联合使用时，可能需要较低剂量的胰岛素或胰岛素促分泌剂，以最大程度地降低低血糖的风险。。

Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene)

会阴坏死性筋膜炎（福尼尔坏疽）

Serious, life-threatening cases requiring urgent surgical intervention have been identified in postmarketing surveillance in both males and females with diabetes mellitus receiving SGLT2 inhibitors. Serious outcomes have included hospitalization, multiple surgeries, and death. Assess patients presenting with pain or tenderness, erythema, or swelling in the genital or perineal areas, along with fever or malaise.

在接受SGLT2抑制剂的男性和女性糖尿病患者的上市后监测中，已经发现需要紧急手术干预的严重危及生命的病例。严重后果包括住院治疗，多次手术和死亡。评估生殖器或会阴区域出现疼痛或压痛，红斑或肿胀以及发烧或不适的患者。

If suspected, start treatment, and discontinue BRENZAVVY..

如果怀疑，开始治疗，停止服用BRENZAVVY。。

Genital Mycotic Infections

生殖器真菌感染

BRENZAVVY increases the risk of genital mycotic infections. Patients who have a history of genital mycotic infections or who are uncircumcised are more likely to develop genital mycotic infections. Monitor and treat appropriately.

BRENZAVVY增加了生殖器真菌感染的风险。有生殖器真菌感染史或未受割礼的患者更有可能发展为生殖器真菌感染。适当监测和治疗。

MOST COMMON ADVERSE REACTIONS (>5%): Female genital mycotic infections, urinary tract infection and increased urination.

最常见的不良反应（>5%）：女性生殖器真菌感染，尿路感染和排尿增加。

USE IN SPECIFIC POPULATIONS

在特定人群中使用

Pregnancy: BRENZAVVY is not recommended during the second and third trimesters.

怀孕：不建议在妊娠中期和晚期使用BRENZAVVY。

Lactation: BRENZAVVY is not recommended when breastfeeding.

哺乳期：母乳喂养时不建议使用BRENZAVVY。

Geriatric patients: There is a higher incidence of adverse reactions related to volume depletion.

老年患者：与体积消耗有关的不良反应发生率较高。

Renal Impairment: There is a higher incidence of adverse reactions related to reduced renal function.

肾功能不全：与肾功能下降有关的不良反应发生率较高。

Hepatic Impairment: BRENZAVVY is not recommended for patients with severe hepatic impairment.

肝功能损害：对于严重肝功能损害的患者，不建议使用Brenzavvvy。

DRUG INTERACTIONS:

药物相互作用：

Inducers of UGT1A9 could result in more rapid clearance of BRENZAVVY by metabolism. Doses of insulin and sulfonylureas may need to be reduced to offset the action of BRENZAVVY. The safety of BRENZAVVY is compromised when it is coupled with insulin or an insulin secretagogue (sulfonylureas and meglitinides – the latter rarely used in the US).

UGT1A9的诱导剂可以通过代谢更快地清除Brenzavvvy。可能需要减少胰岛素和磺脲类药物的剂量以抵消Brenzavvvy的作用。当Brenzavvvy与胰岛素或胰岛素促分泌剂（磺脲类和美格列奈类药物-后者在美国很少使用）结合使用时，其安全性会受到损害。

Lithium carbonate is used as a mood stabilizer in bipolar disorder. Lithium ions might be preferentially (compared to sodium ions) taken up with glucose in the kidney. Empirical evidence has shown that lithium levels can be lower when SGLT2 inhibitors are administered. SGLT2 inhibitors produce pronounced glucosuria, which makes urine testing for glucose diagnostically useless.

碳酸锂被用作双相情感障碍的情绪稳定剂。锂离子可能优先（与钠离子相比）被肾脏中的葡萄糖吸收。经验证据表明，当施用SGLT2抑制剂时，锂水平可能较低。SGLT2抑制剂产生明显的糖尿症，这使得尿液葡萄糖检测在诊断上无用。

Measurements of 1,5 anhydroglucitol are also compromised..

1,5脱水葡萄糖醇的测量也受到影响。。

For additional important safety information about BRENZAVVY, please see the full Prescribing Information.

有关BRENZAVVY的其他重要安全信息，请参阅完整的处方信息。

About TheracosBio

关于TheracosBio

TheracosBio develops novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases.

TheracosBio为具有重大社会影响的疾病开发了新的治疗方法。TheracosBio的使命是扩大常见疾病患者获得新药的机会。

About DiRx

关于DiRx

DiRx is an online mail order pharmacy that delivers significant cost savings on commonly prescribed, FDA-approved medicines without the need for insurance. Founded by industry experts, and licensed to ship prescriptions to all 50 states and the District of Columbia, DiRx draws a straight line from supply to demand to streamline the path between the manufacturer and the consumer.

DiRx是一家在线邮购药店，无需保险即可为FDA批准的常用处方药节省大量成本。DiRx由行业专家创立，并获得许可向所有50个州和哥伦比亚特区运送处方，它从供应到需求绘制了一条直线，以简化制造商和消费者之间的路径。

This lowers costs and makes more medicine accessible to more people. DiRx offers a viable model for businesses and community organizations while simplifying how consumers fill, pay for, and receive maintenance medicine. DiRx has already received recognition from Forbes Health on its 2022 list of ‘Best Online Pharmacies in the country’ and from Fast Company on its 2023 list of ‘Top-10 Most Innovative Companies in Healthcare’.  To learn more, visit DiRxHealth.com, or call 877-FOR-DIRX (877-367-3479)..

这降低了成本，使更多的人可以获得更多的药物。DiRx为企业和社区组织提供了一个可行的模式，同时简化了消费者如何填写，支付和接受维持药物。DiRx已获得《福布斯健康》2022年“全国最佳在线药店”名单和Fast Company 2023年“医疗保健领域十大最具创新公司”名单的认可。要了解更多信息，请访问DiRxHealth.com，或致电877-FOR-DIRX（877-367-3479）。。

Media Contact

媒体联系人

Brian Reid for TheracosBio

布莱恩·里德（TheracosBio）

brian@reidstrategic.com

brian@reidstrategic.com