Viatris Files Supplemental New Drug Applications to Japan's Ministry of Health, Labor and Welfare for the Approval of EFFEXOR® for the Treatment of Generalized Anxiety Disorder
Viatris (VTRS) has filed supplemental New Drug Applications with Japan's Ministry of Health, Labor and Welfare for EFFEXOR® to treat adults with generalized anxiety disorder (GAD). The application follows successful Phase 3 trials where the drug demonstrated superiority over placebo in anxiolytic effects, meeting all seven secondary efficacy endpoints.
The filing aims to introduce the first approved GAD treatment option in Japan, where an estimated 2.6% of the population experiences GAD in their lifetime, with recent studies suggesting a prevalence rate of 7.6%. EFFEXOR®, a serotonin-noradrenaline reuptake inhibitor (SNRI), is already approved for major depressive disorder in Japan and for GAD treatment in over 80 countries globally.
Viatris (VTRS) ha presentato domande supplementari di Nuovo Farmaco presso il Ministero della Salute, del Lavoro e del Welfare giapponese per EFFEXOR®, destinato al trattamento degli adulti con disturbo d'ansia generalizzato (GAD). La richiesta segue i positivi risultati delle sperimentazioni di Fase 3, in cui il farmaco ha dimostrato una superiorità rispetto al placebo negli effetti ansiolitici, raggiungendo tutti e sette gli endpoint secondari di efficacia.
L'obiettivo della domanda è introdurre in Giappone la prima opzione terapeutica approvata per il GAD, una condizione che si stima colpisca il 2,6% della popolazione nel corso della vita, con studi recenti che indicano un tasso di prevalenza del 7,6%. EFFEXOR®, un inibitore della ricaptazione di serotonina e noradrenalina (SNRI), è già approvato in Giappone per il disturbo depressivo maggiore e per il trattamento del GAD in oltre 80 paesi nel mondo.
Viatris (VTRS) ha presentado solicitudes suplementarias de Nuevos Medicamentos ante el Ministerio de Salud, Trabajo y Bienestar de Japón para EFFEXOR®, destinado al tratamiento de adultos con trastorno de ansiedad generalizada (TAG). La solicitud sigue a ensayos de Fase 3 exitosos, donde el medicamento demostró ser superior al placebo en efectos ansiolíticos, cumpliendo con los siete criterios secundarios de eficacia.
El objetivo de la solicitud es introducir la primera opción de tratamiento aprobada para el TAG en Japón, donde se estima que el 2,6% de la población experimenta este trastorno a lo largo de su vida, con estudios recientes que sugieren una tasa de prevalencia del 7,6%. EFFEXOR®, un inhibidor de la recaptación de serotonina y noradrenalina (IRSN), ya está aprobado en Japón para el trastorno depresivo mayor y para el tratamiento del TAG en más de 80 países a nivel mundial.
Viatris (VTRS)는 일본 후생노동성에 EFFEXOR®의 보완 신약 신청서를 제출했습니다. 이 약은 전신성 불안장애(GAD) 성인 환자 치료를 위한 것입니다. 이 신청은 3상 임상시험에서 약물이 위약 대비 불안 완화 효과에서 우수함을 입증하고, 7개의 2차 효능 평가 지표를 모두 충족한 성공적인 결과를 바탕으로 합니다.
이번 신청은 일본에서 처음으로 승인되는 GAD 치료 옵션을 도입하는 것을 목표로 하며, 일본 인구의 약 2.6%가 평생 동안 GAD를 경험하는 것으로 추정되며, 최근 연구에서는 유병률이 7.6%에 달하는 것으로 나타났습니다. EFFEXOR®는 세로토닌-노르에피네프린 재흡수 억제제(SNRI)로서, 일본에서는 주요 우울장애 치료제로 이미 승인되었으며 전 세계 80개국 이상에서 GAD 치료제로 허가받았습니다.
Viatris (VTRS) a déposé des demandes complémentaires de nouveau médicament auprès du Ministère de la Santé, du Travail et du Bien-être du Japon pour EFFEXOR®, destiné au traitement des adultes souffrant de trouble anxieux généralisé (TAG). Cette demande fait suite à des essais de phase 3 réussis, où le médicament a démontré une supériorité par rapport au placebo sur les effets anxiolytiques, atteignant tous les sept critères secondaires d'efficacité.
Le dépôt vise à introduire la première option de traitement approuvée pour le TAG au Japon, où environ 2,6 % de la population souffre de ce trouble au cours de sa vie, avec des études récentes suggérant un taux de prévalence de 7,6 %. EFFEXOR®, un inhibiteur de la recapture de la sérotonine et de la noradrénaline (IRSN), est déjà approuvé au Japon pour le trouble dépressif majeur et pour le traitement du TAG dans plus de 80 pays à travers le monde.
Viatris (VTRS) hat ergänzende Zulassungsanträge für neue Medikamente beim japanischen Ministerium für Gesundheit, Arbeit und Wohlfahrt für EFFEXOR® eingereicht, um Erwachsene mit generalisierter Angststörung (GAD) zu behandeln. Der Antrag folgt erfolgreichen Phase-3-Studien, in denen das Medikament eine Überlegenheit gegenüber Placebo bei anxiolytischen Effekten zeigte und alle sieben sekundären Wirksamkeitsendpunkte erfüllte.
Mit der Einreichung soll die erste zugelassene Behandlungsmöglichkeit für GAD in Japan eingeführt werden, wo schätzungsweise 2,6 % der Bevölkerung im Laufe ihres Lebens an GAD leiden, wobei neuere Studien eine Prävalenzrate von 7,6 % nahelegen. EFFEXOR®, ein Serotonin-Noradrenalin-Wiederaufnahmehemmer (SNRI), ist in Japan bereits zur Behandlung der Major Depression zugelassen und wird weltweit in über 80 Ländern zur Behandlung von GAD eingesetzt.
- First potential approved GAD treatment in Japanese market
- Successful Phase 3 trial results with statistical significance
- Large market opportunity with 7.6% prevalence rate in Japan
- Expansion of existing drug to new indication
- Pending regulatory approval with uncertain timeline
- Potential competition from existing SSRIs and SNRIs in Japanese market
Insights
Viatris' EFFEXOR filing in Japan addresses unmet GAD treatment need with positive Phase 3 results, representing first-to-market opportunity.
Viatris has reached a significant regulatory milestone by filing supplemental New Drug Applications for EFFEXOR® (venlafaxine hydrochloride) with Japan's Ministry of Health, Labor and Welfare. This filing aims to secure approval for treating Generalized Anxiety Disorder (GAD) in adults, an indication where no approved treatment options currently exist in Japan.
The application is supported by compelling clinical evidence from a successful Phase 3 study specifically conducted in Japanese patients. The trial achieved its primary endpoint with statistically significant superiority over placebo (p=0.012) in reducing anxiety symptoms as measured by the Hamilton Anxiety Rating Scale. Importantly, all seven secondary efficacy endpoints were also met, demonstrating robust clinical benefit.
The addressable market appears substantial, with World Health Organization data indicating 2.6
EFFEXOR already holds regulatory approval for major depressive disorder in Japan and for GAD in over 80 countries worldwide. This established global regulatory precedent, combined with the positive Japan-specific clinical data, positions the application favorably. If approved, Viatris would secure first-mover advantage in addressing this specific therapeutic need in the Japanese market.
EFFEXOR filing brings potential first approved GAD treatment to Japan, addressing significant unmet need with proven clinical efficacy.
The supplemental application for EFFEXOR® (venlafaxine hydrochloride) represents a pivotal development for psychiatric care in Japan. As a serotonin-noradrenaline reuptake inhibitor (SNRI), this medication addresses the neurochemical imbalances associated with Generalized Anxiety Disorder through a dual mechanism targeting both key neurotransmitter systems.
The Phase 3 trial design was methodologically robust—placebo-controlled, randomized, and double-blind—providing high-quality evidence for efficacy. The statistically significant improvement in HAM-A scores (p=0.012) represents meaningful symptom reduction for patients suffering from persistent, excessive worry, sleep disturbances, muscle tension, restlessness, and concentration difficulties that characterize GAD.
The prevalence data cited (2.6
For Japanese psychiatrists and patients, this filing represents access to a therapeutic option with established efficacy that's been available internationally for years. The successful trial in Japanese participants confirms efficacy in this specific population. Without approved GAD treatments, Japanese clinicians have lacked evidence-based pharmacological options for a condition that significantly impairs functioning and quality of life. EFFEXOR's potential approval would align Japanese treatment options with international standards of care for this debilitating anxiety disorder.
Aiming to address a significant unmet need for which no other approved treatment option is available for generalized anxiety disorder patients in
As previously announced, our Phase 3 placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in patients with GAD conducted in
"The filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in
Patients with GAD can experience persistent, excessive and uncontrollable anxiety or worry about everyday life activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may impair patients' social, occupational, or other areas of functioning.2 In
Outside of
References
1 Viatris Announces Positive Top-line Results from Phase 3 Study of EFFEXOR® in Japanese Adults with Generalized Anxiety Disorder (GAD)
2 Takahashi, Saburo et al., supervisor of translation; II. Diagnostic Criteria and Code 5 Anxiety Disorders/Generalized Anxiety Disorder (p242-246): DSM-5-TR Diagnostic and Statistical Manual of Mental Disorders, Igaku-Shoin
3 Stein DJ, Kazdin AE, Ruscio AM, et al. Perceived helpfulness of treatment for generalized anxiety disorder: a World Mental Health Surveys report. BMC Psychiatry. 2021;21(1):392.
4 Matsuyama S, Otsubo T, Nomoto K, Higa S, Takashio O. Prevalence of Generalized Anxiety Disorder in
About Generalized Anxiety Disorder (GAD)
Generalized Anxiety Disorder (GAD) is a mental health disorder whose central symptom is chronic and uncontrollable "anxiety" or "worry" about everyday life events or activities. Other symptoms include difficulty to get enough sleep, muscle tension/stiffness, feeling restless, irritable, or finding it difficult to concentrate, which may cause impairment in social, occupational, or other areas of functioning. In
About Viatris
Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the
Forward-Looking Statements
This press release includes statements that constitute "forward-looking statements." 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 regarding the receipt or timing of regulatory approvals; the outcome of clinical trials; the filing of our supplemental New Drug Applications is a key milestone as we move one step closer to bringing the first available treatment option for generalized anxiety disorder to adults in
View original content to download multimedia:https://www.prnewswire.com/news-releases/viatris-files-supplemental-new-drug-applications-to-japans-ministry-of-health-labor-and-welfare-for-the-approval-of-effexor-for-the-treatment-of-generalized-anxiety-disorder-302433284.html
SOURCE Viatris Inc.
FAQ
What are the Phase 3 trial results for Viatris's EFFEXOR in treating GAD in Japan?
How prevalent is Generalized Anxiety Disorder (GAD) in Japan?
What is the current status of GAD treatment options in Japan?
In how many countries is EFFEXOR approved for GAD treatment?
