Sanofi and AstraZeneca Report Results of Nirsevimab in P-III MELODY Study for the Protection of Healthy Infants Against Respiratory Syncytial Virus Disease

Shots:

• 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