- The P-III MELODY study involves evaluating Nirsevimab (50mg/100mg, IM) vs PBO to determine the incidence of medically attended LRTI due to RSV confirmed by RT-PCR testing through 150days after dosing in healthy infants in a ratio (2:1) entering their first RSV season
- The study met its 1EPs i.e. reduction of LRTI due to RSV and the safety profile remains consistent with previously reported results. The regulatory submissions for all-infant indication are expected to begin in 2022
- Nirsevimab is currently being evaluated in P- II/III MEDLEY trial in preterm infants and children with CLD and CHD entering first and second RSV seasons, with expected first data in the coming mos.
Click here to read full press release/ article | Ref: Sanofi | Image: Business Standard