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MSD announced that the Health Sciences Authority (HSA) of Singapore has approved Enflonsia (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants who are born during or entering their first RSV season. Enflonsia is a preventive, long-acting monoclonal antibody (mAb) designed to provide protection through 5-6 months, with the same 105 mg dose regardless of weight. It provides an additional preventive option to help protect newborns and infants born during or entering their first RSV season.
“Infections from RSV can result in serious respiratory conditions in young children, including bronchiolitis and pneumonia,” said Assistant Professor Yeo Kee Thai, senior consultant, Department of Neonatology, KK Women's and Children’s Hospital. He added, “Clinical developments in this space provide us more ways to protect infants from RSV. This is crucial as we strengthen our preventive efforts to minimise the impact of the virus on babies.”
“RSV remains a significant cause of hospitalisation for infants in Singapore and globally. Beyond acute illness, RSV infection in early life has also been associated with a higher risk of subsequent respiratory morbidity, including recurrent wheezing and the development of asthma in childhood. Given the disease burden, we must continue to drive RSV prevention as a public health priority,” said Dr Jenny Tang, senior consultant paediatrician at SBCC Baby & Child Clinic.
Adjunct Associate Professor Agnihotri Biswas, Head & Senior Consultant, Department of Neonatology, Khoo Teck Puat – National University Children's Medical Institute, National University Hospital said, “Unlike many temperate countries with seasonal incidence in winter, RSV circulates throughout the year in a tropical country like Singapore. Incidences of children Public contracting RSV by the time they are two years old are high. The spectrum of symptoms can vary from a mild cold to severe respiratory distress needing hospitalization. Young infants, prematurely born infants and children with certain pre-existing conditions are more likely to demonstrate severe symptoms when infected by RSV. It is important that we continue to raise awareness about RSV prevention and help reduce infant hospitalization.”
Dr Ivan Su, Value & Implementation Lead, MSD Asia Pacific said, “RSV circulates throughout the year in Singapore, with seasonal peaks from May to September. We are pleased that Enflonsia has received HSA approval and is now available for administration in Singapore. Enflonsia is a human monoclonal antibody targeting RSV F protein at site IV, a highly conserved epitope and provides healthcare professionals with another option to protect newborns and infants against mild, moderate, and severe RSV infection. We are committed to ensuring the availability of Enflonsia in Singapore to help reduce the burden of RSV infection on families and health care systems.”
The HSA approval is based on results from the pivotal Phase 2b/3 CLEVER trial (MK-1654-004) evaluating a single dose of Enflonsia administered to preterm and full-term infants (birth to 1 year of age) and Phase 3 SMART trial (MK-1654-007) evaluating the safety and efficacy of Enflonsia versus palivizumab in infants at increased risk for severe RSV disease.
As RSV continues to cause infant hospitalization and serious respiratory conditions, the HSA’s approval of Enflonsia reflects a continuing drive for preventive care and improving patient outcomes. Singapore is the first market in Asia Pacific to receive approval for Enflonsia. Enflonsia (clesrovimab) is now available for administration by the relevant health care providers in Singapore.
Enflonsia (clesrovimab) is MSD’s extended half-life monoclonal antibody (mAb) indicated for passive immunization for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants who are born during or entering their first RSV season. Enflonsia is administered using non-weight-based dosing and is designed to
provide direct, rapid and durable protection through 5-6 months. For infants born during the RSV season, Enflonsia is to be administered starting from birth. For infants born outside of the RSV season, Enflonsia should be administered prior to the start of their first RSV season. For infants undergoing cardiac surgery with cardiopulmonary bypass during or entering their first RSV season, an additional 105 mg dose is recommended as soon as the infant is stable after surgery.
MSD, known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world.
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