MRK · News · 20260806N
Regulatory Approval Milestones
Merck & Co., Inc. · 2026-08-06 · Importance 38 · Surprise 60 · In source text
The U.S. Food and Drug Administration accepted Merck’s supplemental Biologics License Application for ENFLONSIA, also known as clesrovimab-cfor. The application seeks to expand the RSV lower respiratory tract disease prevention indication to children under two years old who face an elevated risk of severe disease during their second RSV season. The FDA acceptance begins the U.S. regulatory review process, but the digest does not provide a target decision date or estimated financial impact.
Key facts
- Merck said the FDA accepted a supplemental BLA for ENFLONSIA (clesrovimab-cfor) to expand its RSV LRTD indication to include children under two years at increased risk for severe RSV through their second season. source
- Merck reported that the FDA has accepted its marketing application to expand the U.S. label for Enflonsia. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | probable | — | Merck said the FDA accepted a supplemental BLA for ENFLONSIA (clesrovimab-cfor) to expand its RSV LRTD indication to include children… |