Merck & Co. announced that Health Canada has approved its RSV preventive therapy ENFLONSIA (clesrovimab) for use in newborns and infants entering their first RSV season. The approval, granted on February 5 2026, allows the company to offer a single 105‑mg dose that provides protection for up to five months, regardless of infant weight.
The decision follows Merck’s June 2025 FDA approval of ENFLONSIA and fits into the company’s broader strategy to diversify beyond its oncology core. By adding a long‑acting monoclonal antibody to its respiratory and infectious‑disease portfolio, Merck gains a new recurring revenue stream that can help offset the impending Keytruda patent cliff and support the 2026 sales guidance of $65.5‑$67.0 billion and non‑GAAP EPS of $5.00‑$5.15.
The RSV vaccine market is projected to reach $3.4 billion by 2034, with a CAGR of 15.2 % from 2026 to 2034. ENFLONSIA’s approval positions Merck to capture a share of this growing segment, competing with Sanofi/AstraZeneca’s Beyfortus and Pfizer’s ABRYSVO. The Canadian market, while smaller than the U.S., offers a high‑demand niche for infant RSV prevention, and the single‑dose convenience of ENFLONSIA could accelerate uptake.
Merck’s Q4 2025 earnings highlighted that the launch of ENFLONSIA in the U.S. contributed to a 4 % increase in its vaccines franchise, offsetting declines in other segments. The Canadian approval is expected to further strengthen the vaccines portfolio, providing a steady revenue source as the company continues to invest in respiratory and cardiometabolic products. Management has emphasized that these launches are part of a deliberate shift toward high‑margin, high‑growth areas outside oncology.
CEO Robert M. Davis noted that “advancing ENFLONSIA into Canada is a key milestone in our strategy to broaden our therapeutic reach and build a more resilient, diversified revenue base.” The approval also aligns with Merck’s recent acquisitions of Verona Pharma and Cidara Therapeutics, reinforcing its commitment to expanding beyond oncology.
Availability in Canada is anticipated in the first quarter of 2027, pending provincial reimbursement decisions. Merck is working with provincial health authorities to secure coverage, which will be critical for market penetration and ensuring that the therapy reaches the infants it is designed to protect.
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