Sanofi (SNY) Form 6-K — Aug 6, 2026
The European Commission has approved an extension of the indication for MenQuadfi to include infants from six weeks of age, expanding the product's market reach and aligning with routine immunization schedules. This approval follows a positive opinion from the Committee for Medicinal Products for Human Use on June 25, 2026, and is supported by comprehensive data from the MET58 pivotal clinical study involving over 6,000 infants across 11 countries.
Key figures
- Dose Regimens
- ["2+1 schedule (0.5mL each, 2-month interval, booster at 12 months)","3+1 schedule (primary at 2, 4, 6 months, booster at 12 months)","Single dose for 12 months and older"]
- Approved Age Range
- six weeks of age
- Clinical Study Size
- 6,000 infants across 11 countries
- Previous Approval Age
- 12 months and older
AI analysis
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