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

April 26, 2021 Auto Bot Against, Clinical Trials, reports, results, Sanofi 0

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: Pharmaceutical Technology

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