Merck announced that Health Canada has approved ENFLONSIA® (clesrovimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates (newborns) and infants born during or entering their first RSV season.
ENFLONSIA® is a monoclonal antibody (mAb) that can help provide protection for up to five months--typical of an RSV season. The Health Canada approval marks an important milestone in expanding RSV prevention options for newborns and infants across Canada. Timing of availability may vary across provinces and territories and will depend on factors including provincial and territorial reimbursement programs.
"RSV can lead to serious respiratory illness, including bronchiolitis and pneumonia, in both healthy and at‑risk infants, and remains one of the leading causes of infant hospitalization," said Matthew Thornhill, Executive Director, Vaccines Business Unit at Merck Canada. "The approval of ENFLONSIA® adds a new option for RSV prevention in infants, supporting efforts to address an important public health concern."
Health Canada's approval is supported by results from Merck's clinical development program, including the pivotal Phase 2b/3 CLEVER trial (MK‑1654‑004) and the Phase 3 SMART trial (MK‑1654‑007).
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