Veltassa® (patiromer) approved in Japan for the treatment of adults with hyperkalemia
CSL Vifor announced that Japan's Ministry of Health and Labor Welfare (MHLW) has approved Veltassa® (patiromer) for treating hyperkalemia in adult patients. This approval, granted to CSL Vifor's partner Zeria Pharmaceutical Co., , marks Veltassa®'s 41st country authorization worldwide.
Veltassa® offers effective long-term potassium control for patients with chronic kidney disease and chronic heart failure. The approval is based on positive clinical data from the Japanese development program of ZG-801 (Veltassa®).
This milestone addresses the needs of over 300,000 hyperkalemia patients in Japan. Zeria, which obtained exclusive rights to develop and market Veltassa® in Japan in 2018, plans to launch the product following National Health Insurance price listing.
CSL Vifor ha annunciato che il Ministero della Salute, del Lavoro e del Welfare del Giappone (MHLW) ha approvato Veltassa® (patiromer) per il trattamento dell'iperpotassiemia in pazienti adulti. Questa approvazione, concessa al partner di CSL Vifor, Zeria Pharmaceutical Co., segna la 41esima autorizzazione di Veltassa® a livello mondiale.
Veltassa® offre un controllo efficace a lungo termine del potassio per i pazienti con malattia renale cronica e insufficienza cardiaca cronica. L'approvazione si basa su dati clinici positivi del programma di sviluppo giapponese di ZG-801 (Veltassa®).
Questo traguardo risponde alle esigenze di oltre 300.000 pazienti con iperpotassiemia in Giappone. Zeria, che ha ottenuto i diritti esclusivi per sviluppare e commercializzare Veltassa® in Giappone nel 2018, prevede di lanciare il prodotto dopo l'inserimento nella lista dei prezzi dell'Assicurazione Sanitaria Nazionale.
CSL Vifor anunció que el Ministerio de Salud, Trabajo y Bienestar de Japón (MHLW) ha aprobado Veltassa® (patiromer) para el tratamiento de la hiperpotasemia en pacientes adultos. Esta aprobación, otorgada al socio de CSL Vifor, Zeria Pharmaceutical Co., marca la 41ª autorización de Veltassa® a nivel mundial.
Veltassa® ofrece un control efectivo del potasio a largo plazo para pacientes con enfermedad renal crónica e insuficiencia cardíaca crónica. La aprobación se basa en datos clínicos positivos del programa de desarrollo japonés de ZG-801 (Veltassa®).
Este hito responde a las necesidades de más de 300,000 pacientes con hiperpotasemia en Japón. Zeria, que obtuvo los derechos exclusivos para desarrollar y comercializar Veltassa® en Japón en 2018, planea lanzar el producto tras la inclusión en la lista de precios de Seguro Nacional de Salud.
CSL Vifor는 일본 후생노동성(MHLW)이 성인 환자의 고칼륨혈증 치료를 위한 Veltassa® (patiromer)를 승인하였다고 발표했다. 이 승인은 CSL Vifor의 파트너인 Zeria Pharmaceutical Co.,에 부여되었으며, 이는 Veltassa®의 전 세계 41번째 국가 승인을 의미한다.
Veltassa®는 만성 신장 질환 및 만성 심부전 환자에게 효과적인 장기 칼륨 조절을 제공한다. 이번 승인은 ZG-801 (Veltassa®)의 일본 개발 프로그램에서 긍정적인 임상 데이터를 기반으로 하고 있다.
이 이정표는 일본 내 30만 명 이상의 고칼륨혈증 환자의 요구에 응답한다. Zeria는 2018년에 일본에서 Veltassa®의 개발 및 판매를 위한 독점 권리를 획득했으며, 국민 건강 보험 가격 목록 후에 제품 출시를 계획하고 있다.
CSL Vifor a annoncé que le ministère de la Santé, du Travail et du Bien-être du Japon (MHLW) a approuvé Veltassa® (patiromer) pour le traitement de l'hyperkaliémie chez les patients adultes. Cette approbation, accordée au partenaire de CSL Vifor, Zeria Pharmaceutical Co., marque la 41e autorisation de Veltassa® dans le monde.
Veltassa® offre un contrôle efficace à long terme du potassium pour les patients atteints de maladie rénale chronique et d'insuffisance cardiaque chronique. L'approbation repose sur des données cliniques positives du programme de développement japonais de ZG-801 (Veltassa®).
Ce jalon répond aux besoins de plus de 300 000 patients souffrant d'hyperkaliémie au Japon. Zeria, qui a obtenu les droits exclusifs de développer et de commercialiser Veltassa® au Japon en 2018, prévoit de lancer le produit après l'inscription du prix dans le système d'assurance santé national.
CSL Vifor hat bekannt gegeben, dass das japanische Ministerium für Gesundheit, Arbeit und Wohlfahrt (MHLW) Veltassa® (patiromer) zur Behandlung von Hyperkaliämie bei erwachsenen Patienten genehmigt hat. Diese Genehmigung, die dem Partner von CSL Vifor, Zeria Pharmaceutical Co., erteilt wurde, stellt die 41. Genehmigung von Veltassa® weltweit dar.
Veltassa® bietet eine effektive langfristige Kontrolle des Kaliums für Patienten mit chronischer Nierenerkrankung und chronischer Herzinsuffizienz. Die Genehmigung basiert auf positiven klinischen Daten aus dem Entwicklungsprogramm von ZG-801 (Veltassa®) in Japan.
Dieser Meilenstein beantwortet die Bedürfnisse von über 300.000 Patienten mit Hyperkaliämie in Japan. Zeria, das 2018 die exklusiven Rechte zur Entwicklung und Vermarktung von Veltassa® in Japan erwarb, plant, das Produkt nach der Preislisteneintragung der nationalen Krankenversicherung einzuführen.
- Veltassa® received approval in Japan for treating hyperkalemia in adults
- Veltassa® has now been authorized in 41 countries worldwide
- The approval addresses the needs of over 300,000 hyperkalemia patients in Japan
- Positive clinical data from the Japanese development program supported the approval
- None.
Veltassa® offers effective and well-tolerated long-term potassium control in chronic kidney disease and chronic heart failure patients 1-5
Zeria Pharmaceutical Co., Ltd. to market Veltassa® in
ST. GALLEN,
"We are pleased that Veltassa® has been approved in
The approval is based on the marketing authorization application filing by Zeria, which was supported by positive clinical data from the Japanese clinical development program of ZG-801 (Veltassa®) conducted in patients with hyperkalemia in
In 2018, CSL Vifor granted Zeria the exclusive right to develop and market Veltassa® in
About CSL Vifor
CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency and nephrology. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
The parent company, CSL (ASX: CSL; USOTC: CSLLY), headquartered in Melbourne,
About hyperkalemia
Hyperkalemia is a serious condition in which the amount of potassium in the blood exceeds the normal level (between 3.5 and 5.0 mmol/L)7. Usually, hyperkalemia remains asymptomatic. However, when the levels of potassium are very high or increase rapidly, people may experience heart palpitations, shortness of breath, chest pain, nausea, or vomiting 8, 9.
The most common causes of high potassium include chronic kidney disease (CKD) and heart failure (HF). Medications used to delay progression of HF and CKD – renin-angiotensin aldosterone system inhibitor (RAASi) – may as well increase the risk of hyperkalemia10.
About Veltassa® (patiromer)
Veltassa® is a sodium-free exchange potassium binder which reduces high amounts of potassium in the blood and maintains the potassium at a normal level. Veltassa® acts within the gastrointestinal tract by exchanging potassium for calcium, primarily in the colon. The potassium is then excreted from the body through the normal excretion process. Veltassa® enables patients to manage chronic hyperkalemia, permitting them to stay on optimal and guideline-recommended doses of life-saving RAASi medications. Veltassa® has demonstrated to enable optimized RAASi therapy use across a range of placebo-controlled, randomized clinical trials in a variety of patient profiles 2,3,11.
As of September 2024, Veltassa® has been approved in 41 countries worldwide, including in the
References:
1. | Bakris GL, et al. JAMA 2015;314:151–61 |
2. | Weir MR, et al. N Engl J Med 2015;372:211–21 |
3. | Pitt B, et al. Eur Heart J 2011;32:820−8; |
4. | Buysse J, et al. Future Cardiol 2012;8:17–28; |
5. | Weir MR, et al. Am J Nephrol. 2024 Aug 19. |
6. | Kashihara N, et al. Kidney Int Rep. 2019; 30;4(9):1248-1260 |
7. | Montford JR, et al. J Am Soc Nephrol 2017;28(11):3155–65. |
8. | Campese VM, et al. Kidney Int Suppl 2016;6(1):16–19. |
9. | Cleveland Clinic. Hyperkalemia (High Potassium) available at: https://my.clevelandclinic.org/health/diseases/15184-hyperkalemia-high-blood-potassium. Date accessed: September 2024. |
10. | Dunn JD, et al. Am J Manag Care 2015;21:S307–15. |
11. | Agarwal R, et al. Lancet 2019;394:1540–50 |
CSL Vifor Media Contact
Thomas Hutter
+41 79 957 96 73
media@viforpharma.com
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SOURCE Vifor International AG (CSL Vifor)
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