Merck Announces FDA Acceptance of Biologics License Application for Clesrovimab, an Investigational Long-Acting Monoclonal Antibody Designed to Protect Infants from RSV Disease During their First RSV Season
Merck (MRK) announced FDA acceptance of its Biologics License Application (BLA) for clesrovimab, a long-acting monoclonal antibody designed to protect infants from RSV disease. The FDA set a target action date of June 10, 2025.
The application is supported by results from the Phase 2b/3 CLEVER trial and interim results from the ongoing Phase 3 SMART trial, which evaluated clesrovimab's safety and efficacy in healthy preterm and full-term infants. If approved, clesrovimab would be the first and only single dose immunization for infants regardless of weight, protecting them throughout their first RSV season.
Merck anticipates making clesrovimab available for ordering by July 2025, in time for the 2025-26 RSV season.
Merck (MRK) ha annunciato che la FDA ha accettato la sua domanda di licenza biologica (BLA) per clesrovimab, un anticorpo monoclonale a lunga durata progettato per proteggere i neonati dalla malattia RSV. La FDA ha stabilito una data target per l'azione del 10 giugno 2025.
La domanda è supportata dai risultati dello studio CLEVER di fase 2b/3 e dai risultati intermedi dello studio di fase 3 SMART in corso, che hanno valutato la sicurezza e l'efficacia di clesrovimab in neonati nati prematuri e a termine. Se approvato, clesrovimab sarebbe la prima e unica immunizzazione a dose unica per i neonati, indipendentemente dal peso, proteggendoli per tutta la loro prima stagione RSV.
Merck prevede di rendere disponibile clesrovimab per ordini entro luglio 2025, in tempo per la stagione RSV 2025-26.
Merck (MRK) anunció la aceptación por parte de la FDA de su Solicitud de Licencia Biológica (BLA) para clesrovimab, un anticuerpo monoclonal de acción prolongada diseñado para proteger a los bebés de la enfermedad RSV. La FDA ha establecido una fecha de acción objetivo del 10 de junio de 2025.
La solicitud cuenta con el respaldo de los resultados del estudio CLEVER de fase 2b/3 y resultados interinos del estudio en fase 3 SMART en curso, que evaluaron la seguridad y eficacia de clesrovimab en bebés prematuros y a término sanos. Si se aprueba, clesrovimab sería la primera y única inmunización de dosis única para bebés sin importar su peso, protegiéndolos durante toda su primera temporada de RSV.
Merck anticipa que clesrovimab estará disponible para pedidos a partir de julio de 2025, a tiempo para la temporada de RSV 2025-26.
머크 (MRK)는 클레스로비맙에 대한 생물학적 라이센스 신청(BLA)이 FDA에 의해 수락되었다고 발표했습니다. 이는 신생아를 RSV 질병으로부터 보호하기 위해 설계된 장기 작용 단클론 항체입니다. FDA는 2025년 6월 10일을 목표 조치 날짜로 설정했습니다.
이 신청서는 건강한 미숙아 및 만삭 아기에서 클레스로비맙의 안전성과 효능을 평가한 2b/3상 CLEVER 시험과 진행 중인 3상 SMART 시험의 중간 결과에 의해 뒷받침됩니다. 승인이 날 경우, 클레스로비맙은 모든 체중의 신생아를 위한 첫 번째이자 유일한 단일 용량 면역접종이 되어, 그들의 첫 번째 RSV 시즌 내내 보호할 것입니다.
머크는 2025년 7월까지 클레스로비맙을 주문할 수 있도록 할 계획이며, 2025-26 RSV 시즌을 위한 준비가 될 것입니다.
Merck (MRK) a annoncé que la FDA a accepté sa demande de licence biologique (BLA) pour clesrovimab, un anticorps monoclonal à action prolongée conçu pour protéger les nourrissons contre la maladie RSV. La FDA a fixé une date cible pour l'action au 10 juin 2025.
La demande est soutenue par les résultats de l'essai CLEVER de phase 2b/3 et les résultats intermédiaires de l'essai SMART de phase 3 en cours, qui ont évalué la sécurité et l'efficacité de clesrovimab chez des nourrissons prématurés et à terme en bonne santé. S'il est approuvé, clesrovimab serait la première et unique vaccination à dose unique pour les nourrissons, quel que soit leur poids, les protégeant durant leur première saison de RSV.
Merck prévoit de rendre clesrovimab disponible à la commande d'ici juillet 2025, juste à temps pour la saison RSV 2025-26.
Merck (MRK) gab bekannt, dass die FDA ihren Antrag auf Biologika-Lizenz (BLA) für clesrovimab angenommen hat, einen langwirksamen monoklonalen Antikörper, der zur Anwendung bei Säuglingen zur Prävention der RSV-Krankheit entwickelt wurde. Die FDA hat ein Zieltermin für die Entscheidung auf den 10. Juni 2025 festgelegt.
Der Antrag wird durch die Ergebnisse der Phase 2b/3 CLEVER-Studie und vorläufige Ergebnisse der laufenden Phase 3 SMART-Studie unterstützt, die die Sicherheit und Wirksamkeit von clesrovimab bei gesunden Früh- und Termingeborenen untersucht haben. Bei Genehmigung wäre clesrovimab die erste und einzige Einzeldosis-Impfung für Säuglinge unabhängig von ihrem Gewicht und würde sie während ihrer ersten RSV-Saison schützen.
Merck plant, clesrovimab ab Juli 2025 zur Bestellung anzubieten, rechtzeitig für die RSV-Saison 2025-26.
- FDA acceptance of BLA for clesrovimab with PDUFA date set
- Potential first-mover advantage in single-dose RSV protection for infants
- Promising results from Phase 2b/3 CLEVER and Phase 3 SMART trials
- Clear commercialization timeline targeting 2025-26 RSV season
- Extended timeline to potential revenue generation (mid-2025)
- Pending FDA approval creates regulatory uncertainty
Insights
The FDA acceptance of Merck's BLA for clesrovimab represents a significant advancement in RSV prevention. This long-acting monoclonal antibody's unique selling point is its single-dose administration that provides protection throughout an infant's first RSV season, regardless of weight. The CLEVER and SMART trials' positive data supporting the application demonstrate strong clinical validation. The June 10, 2025 PDUFA date positions Merck to potentially capture market share in the 2025-26 RSV season.
The timing is strategic as it addresses an existing gap in the RSV prevention market. While recent advances have emerged, the single-dose administration could provide a competitive advantage over current options. The potential commercial launch by July 2025 aligns well with seasonal RSV patterns, maximizing the product's market impact.
This regulatory milestone could significantly impact Merck's revenue potential in the growing RSV prevention market. The global RSV therapeutics market is projected to expand substantially and a successful launch could generate meaningful revenue streams. Merck's strategic positioning with a single-dose administration differentiates it from competitors and could drive market penetration.
The timing of the potential approval and launch before the 2025-26 RSV season allows for proper market preparation and healthcare system integration. If approved, clesrovimab could strengthen Merck's infectious disease portfolio and provide a new growth driver. The company's $253.98B market cap reflects strong fundamentals and this development could further enhance shareholder value.
If approved, clesrovimab has the potential to be available to help address the burden of RSV disease in the
“Despite recent advances in RSV prevention, unmet needs remain for additional effective interventions to help protect infants and continue to help address the burden RSV places on families and the healthcare system. This regulatory milestone, along with promising results from our pivotal studies demonstrating efficacy in the prevention of RSV disease, marks important progress toward our goal of having clesrovimab available in time for the 2025-26 RSV season,” said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories. “We look forward to working alongside the FDA on the review of clesrovimab, which, if approved, would be the first and only single dose immunization for infants regardless of weight designed to protect them for the duration of their first RSV season.”
The application is supported by results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004), a randomized placebo-controlled trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age), and interim results from the ongoing Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease. Data from these trials were presented during IDWeek in October 2024.
If approved, Merck anticipates that clesrovimab would be available for ordering by physicians and healthcare administrators by July 2025, with shipments to arrive in time for the 2025 RSV season.
About clesrovimab (MK-1654)
Clesrovimab (MK-1654) is an investigational, extended half-life monoclonal antibody (mAb) developed as a passive immunization for the prevention of RSV disease. Clesrovimab is designed to be administered as the same single dose, regardless of weight, and is being studied in healthy preterm, full-term and at-risk infants to provide direct, rapid, and durable protection through their first RSV season against mild, moderate and severe RSV.
About Merck’s commitment to global supply and access of clesrovimab
Since the discovery of clesrovimab, our investigational respiratory syncytial virus (RSV) monoclonal antibody (mAb), our goal has been to facilitate global access to this intervention. We are diligently developing our regulatory and access strategies, as well as our supply chain to be fit-for-purpose for low- and middle-income countries by utilizing diversified internal investments and external partnerships. The company is working with urgency to submit licensure applications to address unmet needs for RSV prevention globally.
About RSV
Respiratory syncytial virus (RSV) is a contagious virus that causes widespread seasonal infections like the flu, with a worldwide burden in infants and older adults. There is high unmet need for preventative options in both healthy and high-risk infants. Globally, RSV is the leading cause of hospitalization for healthy infants under a year old, and a major cause of death in low- and middle-income countries. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 3.6 million hospitalizations and 101,000 deaths a year worldwide in children under five. According to the CDC, RSV season starts in the fall and peaks in the winter in most regions of
About Merck
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FAQ
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